Trial Outcomes & Findings for Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults (NCT NCT01497899)
NCT ID: NCT01497899
Last Updated: 2018-11-19
Results Overview
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
279 participants
Primary outcome timeframe
Week 24
Results posted on
2018-11-19
Participant Flow
Participants were enrolled at study sites in the United States and Puerto Rico. The first participant was screened on 28 December 2011. The last study visit occurred on 22 August 2016.
232 participants were screened for the Double-Blind Phase. 108 participants from other Gilead-sponsored Study GS-US-299-0102 joined the Open-Label Extension Phase.
Participant milestones
| Measure |
E/C/F/TAF
Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
E/C/F/TDF
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
D/C/F/TAF to Open-Label E/C/F/TAF
Participants previously received darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
|
DRV+COBI+TVD to Open-Label E/C/F/TAF
Participants previously received darunavir (DRV) + cobicistat (COBI) + Truvada® (TVD) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
|
|---|---|---|---|---|
|
Double-Blind Phase
STARTED
|
113
|
58
|
0
|
0
|
|
Double-Blind Phase
COMPLETED
|
107
|
53
|
0
|
0
|
|
Double-Blind Phase
NOT COMPLETED
|
6
|
5
|
0
|
0
|
|
Open-Label Extension Phase
STARTED
|
105
|
53
|
70
|
38
|
|
Open-Label Extension Phase
COMPLETED
|
86
|
46
|
61
|
33
|
|
Open-Label Extension Phase
NOT COMPLETED
|
19
|
7
|
9
|
5
|
Reasons for withdrawal
| Measure |
E/C/F/TAF
Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
E/C/F/TDF
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
D/C/F/TAF to Open-Label E/C/F/TAF
Participants previously received darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
|
DRV+COBI+TVD to Open-Label E/C/F/TAF
Participants previously received darunavir (DRV) + cobicistat (COBI) + Truvada® (TVD) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
|
|---|---|---|---|---|
|
Double-Blind Phase
Randomized but not Treated
|
1
|
0
|
0
|
0
|
|
Double-Blind Phase
Adverse Event
|
1
|
0
|
0
|
0
|
|
Double-Blind Phase
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Double-Blind Phase
Investigator's Discretion
|
1
|
0
|
0
|
0
|
|
Double-Blind Phase
Withdrew Consent
|
0
|
1
|
0
|
0
|
|
Double-Blind Phase
Lost to Follow-up
|
3
|
2
|
0
|
0
|
|
Double-Blind Phase
Subject Non-Compliance
|
0
|
1
|
0
|
0
|
|
Open-Label Extension Phase
Adverse Event
|
1
|
0
|
0
|
0
|
|
Open-Label Extension Phase
Death
|
1
|
0
|
0
|
0
|
|
Open-Label Extension Phase
Withdrew Consent
|
8
|
3
|
2
|
0
|
|
Open-Label Extension Phase
Pregnancy
|
0
|
1
|
1
|
0
|
|
Open-Label Extension Phase
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Open-Label Extension Phase
Lost to Follow-up
|
9
|
3
|
5
|
5
|
Baseline Characteristics
Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Baseline characteristics by cohort
| Measure |
E/C/F/TAF
n=112 Participants
Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
E/C/F/TDF
n=58 Participants
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
D/C/F/TAF to Open-Label E/C/F/TAF
n=70 Participants
Participants previously received D/C/F/TAF in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
|
DRV+COBI+TVD to Open-Label E/C/F/TAF
n=38 Participants
Participants previously received DRV+COBI+TVD in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
|
Total
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
37 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
36 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
37 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
36 years
STANDARD_DEVIATION 11.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
267 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis Set: participants randomized to the Double-Blind Phase and received at least 1 dose of study drug.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
E/C/F/TAF
n=112 Participants
Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
E/C/F/TDF
n=58 Participants
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
|
88.4 percentage of participants
|
89.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Set
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
E/C/F/TAF
n=112 Participants
Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
E/C/F/TDF
n=58 Participants
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
|
88.4 percentage of participants
|
87.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24 and 48Population: Participants in Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=112 Participants
Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
E/C/F/TDF
n=58 Participants
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
|---|---|---|
|
Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48
Baseline
|
4.63 log10 copies/mL
Standard Deviation 0.572
|
4.69 log10 copies/mL
Standard Deviation 0.577
|
|
Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48
Change at Week 24
|
-3.20 log10 copies/mL
Standard Deviation 0.654
|
-3.26 log10 copies/mL
Standard Deviation 0.606
|
|
Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48
Change at Week 48
|
-3.22 log10 copies/mL
Standard Deviation 0.606
|
-3.33 log10 copies/mL
Standard Deviation 0.572
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24 and 48Population: Participants in Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=112 Participants
Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks
Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
E/C/F/TDF
n=58 Participants
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks
Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Change at Week 48
|
177 cells/uL
Standard Deviation 144.1
|
204 cells/uL
Standard Deviation 120.4
|
|
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Baseline
|
404 cells/uL
Standard Deviation 181.6
|
394 cells/uL
Standard Deviation 209.6
|
|
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Change at Week 24
|
165 cells/uL
Standard Deviation 115.6
|
179 cells/uL
Standard Deviation 127.7
|
Adverse Events
E/C/F/TAF
Serious events: 12 serious events
Other events: 91 other events
Deaths: 0 deaths
E/C/F/TDF
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
All E/C/F/TAF
Serious events: 35 serious events
Other events: 215 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E/C/F/TAF
n=112 participants at risk
Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TAF.
Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks; Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
E/C/F/TDF
n=58 participants at risk
Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TDF.
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks; Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
All E/C/F/TAF
n=273 participants at risk
Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF.
Participants received blinded or open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Cardiac disorders
Acute myocardial infarction
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.73%
2/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Cardiac disorders
Coronary artery disease
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Cardiac disorders
Pericarditis
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.7%
1/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
General disorders
Systemic inflammatory response syndrome
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.73%
2/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Appendicitis
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.5%
4/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Cellulitis
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.73%
2/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.7%
1/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Coxsackie viral infection
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Erysipelas
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Furuncle
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Neurosyphilis
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Pneumonia
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.73%
2/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Pyelonephritis
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Sinusitis
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Upper respiratory tract infection
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Viral infection
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Viral rash
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.7%
1/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.7%
1/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Nervous system disorders
Vertebral artery dissection
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Psychiatric disorders
Bipolar disorder
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.1%
3/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Psychiatric disorders
Depression
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.1%
3/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Psychiatric disorders
Suicidal ideation
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.73%
2/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.37%
1/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.7%
1/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
Other adverse events
| Measure |
E/C/F/TAF
n=112 participants at risk
Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TAF.
Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks; Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
E/C/F/TDF
n=58 participants at risk
Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TDF.
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks; Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
All E/C/F/TAF
n=273 participants at risk
Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF.
Participants received blinded or open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily
|
|---|---|---|---|
|
Infections and infestations
Syphilis
|
4.5%
5/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
13.9%
38/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Endocrine disorders
Hypogonadism
|
6.2%
7/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
4.4%
12/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Constipation
|
3.6%
4/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.7%
10/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Diarrhoea
|
17.0%
19/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
15.5%
9/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
14.7%
40/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
4/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.3%
9/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Flatulence
|
5.4%
6/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
2.2%
6/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Nausea
|
22.3%
25/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
12.1%
7/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
12.8%
35/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Toothache
|
2.7%
3/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.7%
1/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.5%
15/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
9/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
6.9%
4/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
6.2%
17/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
General disorders
Fatigue
|
16.1%
18/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
8.6%
5/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
10.6%
29/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Immune system disorders
Seasonal allergy
|
3.6%
4/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
4.0%
11/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Acarodermatitis
|
3.6%
4/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
2.9%
8/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Bronchitis
|
6.2%
7/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
12.1%
33/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Chlamydial infection
|
2.7%
3/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.9%
16/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Conjunctivitis
|
8.0%
9/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
6.6%
18/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Gastroenteritis
|
3.6%
4/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
9.5%
26/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Influenza
|
7.1%
8/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
7.0%
19/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
7/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
11.4%
31/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Pharyngitis
|
8.9%
10/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
7.3%
20/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Sinusitis
|
6.2%
7/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
10.3%
28/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Infections and infestations
Upper respiratory tract infection
|
15.2%
17/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
20.7%
12/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
22.0%
60/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.7%
3/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.1%
14/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.7%
3/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.7%
1/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
7.0%
19/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
5/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
6.6%
18/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
3/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
13.8%
8/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
9.9%
27/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.7%
3/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.5%
4/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
3.6%
4/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.1%
14/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.89%
1/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
4.4%
12/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anorectal human papilloma virus infection
|
5.4%
6/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
6.9%
4/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
0.00%
0/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.5%
4/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Nervous system disorders
Headache
|
9.8%
11/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
13.8%
8/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
9.5%
26/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Nervous system disorders
Paraesthesia
|
2.7%
3/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
6.9%
4/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
2.6%
7/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Psychiatric disorders
Abnormal dreams
|
7.1%
8/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.7%
1/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
2.9%
8/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Psychiatric disorders
Anxiety
|
3.6%
4/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
8.6%
5/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.5%
15/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Psychiatric disorders
Depression
|
9.8%
11/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
3.4%
2/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
9.9%
27/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Psychiatric disorders
Insomnia
|
5.4%
6/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
6.9%
4/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.1%
14/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.8%
11/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
10.3%
6/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
13.2%
36/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.6%
4/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
1.7%
1/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.1%
14/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.8%
11/112 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
5.2%
3/58 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
8.1%
22/273 • Up to 186.2 weeks plus 30 days
* Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug. * Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0 * All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER