Trial Outcomes & Findings for Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants (NCT NCT01815736)
NCT ID: NCT01815736
Last Updated: 2021-04-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1443 participants
Primary outcome timeframe
Week 48
Results posted on
2021-04-13
Participant Flow
Participants were enrolled at study sites in Dominican Republic, Puerto Rico, North America, South America, Europe, Australia, and Asia. The first participant was screened on 27 March 2013. The last study visit occurred on 01 April 2020.
1559 participants were screened.
Participant milestones
| Measure |
E/C/F/TAF
Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered once daily for up to 96 weeks.
Extension Phase: After completing 96 weeks of randomized treatment, all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
|
Stay on Baseline Treatment Regimen (SBR)
Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks.
Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
|
|---|---|---|
|
Randomized Treatment Phase-Up to Week 96
STARTED
|
963
|
480
|
|
Randomized Treatment Phase-Up to Week 96
COMPLETED
|
914
|
445
|
|
Randomized Treatment Phase-Up to Week 96
NOT COMPLETED
|
49
|
35
|
|
Extension Treatment Phase- After Week 96
STARTED
|
905
|
424
|
|
Extension Treatment Phase- After Week 96
COMPLETED
|
854
|
398
|
|
Extension Treatment Phase- After Week 96
NOT COMPLETED
|
51
|
26
|
Reasons for withdrawal
| Measure |
E/C/F/TAF
Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered once daily for up to 96 weeks.
Extension Phase: After completing 96 weeks of randomized treatment, all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
|
Stay on Baseline Treatment Regimen (SBR)
Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks.
Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
|
|---|---|---|
|
Randomized Treatment Phase-Up to Week 96
Withdrew Consent
|
11
|
17
|
|
Randomized Treatment Phase-Up to Week 96
Lost to Follow-up
|
10
|
9
|
|
Randomized Treatment Phase-Up to Week 96
Investigator's Discretion
|
11
|
2
|
|
Randomized Treatment Phase-Up to Week 96
Adverse Event
|
7
|
4
|
|
Randomized Treatment Phase-Up to Week 96
Death
|
4
|
0
|
|
Randomized Treatment Phase-Up to Week 96
Lack of Efficacy
|
1
|
0
|
|
Randomized Treatment Phase-Up to Week 96
Pregnancy
|
1
|
0
|
|
Randomized Treatment Phase-Up to Week 96
Participants randomized and never treated
|
4
|
3
|
|
Extension Treatment Phase- After Week 96
Investigator's Discretion
|
31
|
15
|
|
Extension Treatment Phase- After Week 96
Lost to Follow-up
|
13
|
9
|
|
Extension Treatment Phase- After Week 96
Withdrew Consent
|
5
|
1
|
|
Extension Treatment Phase- After Week 96
Adverse Event
|
1
|
1
|
|
Extension Treatment Phase- After Week 96
Death
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
Baseline characteristics by cohort
| Measure |
E/C/F/TAF
n=959 Participants
Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF)(150/150/200/10 mg) fixed-dose combination (FDC) tablet administered once daily for up to 96 weeks.
Extension Phase: After completing 96 weeks of randomized treatment, all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
|
Stay on Baseline Treatment Regimen (SBR)
n=477 Participants
Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks.
Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
|
Total
n=1436 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
41 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
41 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
856 Participants
n=5 Participants
|
427 Participants
n=7 Participants
|
1283 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
59 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
169 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
651 Participants
n=5 Participants
|
314 Participants
n=7 Participants
|
965 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Local regulators did not allow collection of race or ethnicity information
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
67 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
248 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
709 Participants
n=5 Participants
|
392 Participants
n=7 Participants
|
1101 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Local regulators did not allow collection of race or ethnicity information
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
648 participants
n=5 Participants
|
316 participants
n=7 Participants
|
964 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=5 Participants
|
8 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
35 participants
n=5 Participants
|
21 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
51 participants
n=5 Participants
|
27 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
16 participants
n=5 Participants
|
8 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=5 Participants
|
8 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
14 participants
n=5 Participants
|
5 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
29 participants
n=5 Participants
|
13 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
19 participants
n=5 Participants
|
6 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
38 participants
n=5 Participants
|
22 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Region of Enrollment
France
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
34 participants
n=5 Participants
|
11 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
HIV-1 RNA Category
< 50 copies/mL
|
943 Participants
n=5 Participants
|
466 Participants
n=7 Participants
|
1409 Participants
n=5 Participants
|
|
HIV-1 RNA Category
≥ 50 copies/mL
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Full Analysis Set included participants who were randomized and received at least 1 dose of study drug. New Drug Application (NDA Data Cut) = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
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=959 Participants
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Stay on Baseline Treatment Regimen (SBR)
n=477 Participants
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
All Participants
|
97.2 percentage of participants
|
93.1 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
NDA Data Cut
|
95.6 percentage of participants
|
92.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Hip DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm\^2); the mean (SD) percentage change is presented.
Outcome measures
| Measure |
E/C/F/TAF
n=902 Participants
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Stay on Baseline Treatment Regimen (SBR)
n=452 Participants
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
|---|---|---|
|
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
NDA Data Cut
|
1.949 percentage change
Standard Deviation 2.9956
|
-0.136 percentage change
Standard Deviation 2.9890
|
|
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
All Participants
|
1.468 percentage change
Standard Deviation 2.7136
|
-0.340 percentage change
Standard Deviation 2.8280
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Spine DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
Spine BMD was assessed by DXA scan. BMD is calculated as g/cm\^2; the mean (SD) percentage change is presented.
Outcome measures
| Measure |
E/C/F/TAF
n=912 Participants
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Stay on Baseline Treatment Regimen (SBR)
n=457 Participants
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 48
NDA Data Cut
|
1.861 percentage change
Standard Deviation 3.0889
|
-0.110 percentage change
Standard Deviation 3.7415
|
|
Percent Change From Baseline in Spine BMD at Week 48
All Participants
|
1.557 percentage change
Standard Deviation 3.8441
|
-0.443 percentage change
Standard Deviation 4.1387
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Safety Analysis Set (randomized participants who received ≥ 1 dose of study drug) excluding participants with prior treatment of EFV/FTC/TDF. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut
Outcome measures
| Measure |
E/C/F/TAF
n=708 Participants
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Stay on Baseline Treatment Regimen (SBR)
n=352 Participants
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
|---|---|---|
|
Change From Baseline in Serum Creatinine at Week 48
NDA Data Cut
|
-0.01 mg/dL
Standard Deviation 0.117
|
0.04 mg/dL
Standard Deviation 0.123
|
|
Change From Baseline in Serum Creatinine at Week 48
All Participants
|
0.00 mg/dL
Standard Deviation 0.115
|
0.03 mg/dL
Standard Deviation 0.105
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in EFV-Related Symptom Analysis Set with available data were analyzed. NDA Data Cut = participants through data cut for E/C/F/TAF NDA; All Participants = participants through Week 48 Data Cut
The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement. EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit.
Outcome measures
| Measure |
E/C/F/TAF
n=239 Participants
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Stay on Baseline Treatment Regimen (SBR)
n=116 Participants
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
|---|---|---|
|
Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48
NDA Data Cut
|
-1.6 units on a scale
Standard Deviation 3.06
|
-0.1 units on a scale
Standard Deviation 2.43
|
|
Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48
All Participants
|
-1.5 units on a scale
Standard Deviation 3.06
|
-0.1 units on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 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=959 Participants
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Stay on Baseline Treatment Regimen (SBR)
n=477 Participants
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
|
92.8 percentage of participants
|
89.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
The percentage of participants achieving HIV-1 RNA \< 20 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=959 Participants
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Stay on Baseline Treatment Regimen (SBR)
n=477 Participants
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48
NDA Data Cut
|
92.2 percentage of participants
|
90.4 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48
All Participants
|
93.5 percentage of participants
|
90.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 96 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=959 Participants
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Stay on Baseline Treatment Regimen (SBR)
n=477 Participants
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96
|
90.6 percentage of participants
|
85.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed. NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut.
The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
Outcome measures
| Measure |
E/C/F/TAF
n=959 Participants
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Stay on Baseline Treatment Regimen (SBR)
n=477 Participants
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
|---|---|---|
|
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Baseline (NDA Data Cut)
|
712 cells/uL
Standard Deviation 267.9
|
690 cells/uL
Standard Deviation 251.4
|
|
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Change at Week 48 (NDA Data Cut)
|
33 cells/uL
Standard Deviation 166.6
|
27 cells/uL
Standard Deviation 160.2
|
|
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Baseline (All Participants)
|
701 cells/uL
Standard Deviation 261.8
|
689 cells/uL
Standard Deviation 248.0
|
|
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Change at Week 48 (All Participants)
|
35 cells/uL
Standard Deviation 164.6
|
24 cells/uL
Standard Deviation 156.1
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
Outcome measures
| Measure |
E/C/F/TAF
n=959 Participants
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Stay on Baseline Treatment Regimen (SBR)
n=477 Participants
Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen (E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF)) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Weeks 96
Baseline
|
701 cells/uL
Standard Deviation 261.8
|
689 cells/uL
Standard Deviation 248.0
|
|
Change From Baseline in CD4 Cell Count at Weeks 96
Change at Week 96
|
60 cells/uL
Standard Deviation 181.6
|
42 cells/uL
Standard Deviation 158.0
|
Adverse Events
Randomized Phase: E/C/F/TAF
Serious events: 79 serious events
Other events: 620 other events
Deaths: 4 deaths
Randomized Phase: Stay on Baseline Treatment Regimen (SBR)
Serious events: 39 serious events
Other events: 286 other events
Deaths: 0 deaths
Extension Phase: E/C/F/TAF From E/C/F/TAF
Serious events: 27 serious events
Other events: 298 other events
Deaths: 1 deaths
Extension Phase: E/C/F/TAF From SBR
Serious events: 22 serious events
Other events: 144 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Randomized Phase: E/C/F/TAF
n=959 participants at risk
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; EVG/COBI/FTC/TAF; E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Randomized Phase: Stay on Baseline Treatment Regimen (SBR)
n=477 participants at risk
Participants stayed on their baseline emtricitabine(FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
Extension Phase: E/C/F/TAF From E/C/F/TAF
n=905 participants at risk
After completing 96 weeks of randomized treatment (E/C/F/TAF), all participants were given the opportunity to receive open-label E/C/F/TAF in the extension phase until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
|
Extension Phase: E/C/F/TAF From SBR
n=424 participants at risk
After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF in the extension phase until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.42%
2/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.21%
2/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.21%
2/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Cardiac disorders
Myocarditis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Eye disorders
Retinal detachment
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
3/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.47%
2/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Colitis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.42%
2/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.47%
2/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Enteritis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
Chest pain
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.47%
2/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
Chills
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
Fatigue
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
General physical health deterioration
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
Non-cardiac chest pain
|
0.21%
2/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
Pyrexia
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.47%
2/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
Sudden death
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
Vascular stent occlusion
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Immune system disorders
Anaphylactic reaction
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Acute hepatitis C
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Anal abscess
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Appendicitis
|
0.31%
3/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Bacterial colitis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Bronchitis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.42%
2/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.22%
2/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Enteritis infectious
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Gonorrhoea
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
H1n1 influenza
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Hepatitis A
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Hepatitis syphilitic
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.42%
2/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Meningitis aseptic
|
0.31%
3/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Neurosyphilis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Osteomyelitis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.42%
2/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Perineal infection
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Pneumonia
|
0.52%
5/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.47%
2/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Reiter's syndrome
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Secondary syphilis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Maternal exposure during pregnancy
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Sepsis
|
0.42%
4/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Septic shock
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Sinusitis
|
0.21%
2/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Urinary tract infection
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Viral infection
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Ataxia
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Febrile convulsion
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Headache
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Memory impairment
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Migraine
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Seizure
|
0.21%
2/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Product Issues
Device breakage
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Acute psychosis
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Alcohol abuse
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.42%
2/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Hallucination
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Major depression
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Mental status changes
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.21%
2/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Suicide attempt
|
0.42%
4/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.42%
2/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Renal and urinary disorders
Bladder disorder
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Renal and urinary disorders
Fanconi syndrome acquired
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.21%
2/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.24%
1/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
1/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Social circumstances
Substance use
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.11%
1/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.21%
1/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.00%
0/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
Other adverse events
| Measure |
Randomized Phase: E/C/F/TAF
n=959 participants at risk
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; EVG/COBI/FTC/TAF; E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase.
|
Randomized Phase: Stay on Baseline Treatment Regimen (SBR)
n=477 participants at risk
Participants stayed on their baseline emtricitabine(FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase.
|
Extension Phase: E/C/F/TAF From E/C/F/TAF
n=905 participants at risk
After completing 96 weeks of randomized treatment (E/C/F/TAF), all participants were given the opportunity to receive open-label E/C/F/TAF in the extension phase until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
|
Extension Phase: E/C/F/TAF From SBR
n=424 participants at risk
After completing 96 weeks of randomized treatment (SBR), all participants were given the opportunity to receive open-label E/C/F/TAF in the extension phase until it became commercially available, or until Gilead elected to terminate the development of E/C/F/TAF.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
109/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
10.7%
51/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
4.4%
40/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
5.2%
22/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
56/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
3.8%
18/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.88%
8/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
3.1%
13/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
General disorders
Pyrexia
|
5.0%
48/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
4.4%
21/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
0.77%
7/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.4%
6/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Bronchitis
|
7.2%
69/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
5.5%
26/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.9%
17/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
3.1%
13/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Syphilis
|
6.6%
63/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
8.0%
38/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
2.1%
19/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
2.1%
9/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
96/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
10.1%
48/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
5.2%
47/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
4.7%
20/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Pharyngitis
|
5.8%
56/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
2.9%
14/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.7%
15/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.2%
5/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Sinusitis
|
6.0%
58/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
6.5%
31/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
2.8%
25/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
2.1%
9/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.5%
168/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
13.4%
64/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
7.4%
67/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
6.1%
26/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
78/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
6.5%
31/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
2.1%
19/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.9%
8/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
70/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
6.9%
33/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
3.3%
30/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
2.1%
9/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
7.0%
67/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
5.2%
25/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
3.1%
28/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
3.1%
13/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Nervous system disorders
Headache
|
8.7%
83/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
5.2%
25/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
2.0%
18/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
2.1%
9/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Depression
|
5.0%
48/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
6.3%
30/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.7%
15/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.7%
7/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Psychiatric disorders
Insomnia
|
6.0%
58/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
7.5%
36/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.3%
12/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.9%
8/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.6%
73/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
6.5%
31/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
3.1%
28/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
3.1%
13/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
57/959 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
2.5%
12/477 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.1%
10/905 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
1.7%
7/424 • From the first dose date up to last dose date ( maximum: 307.7 weeks) plus 30 days
Safety Analysis Set included participants who were randomized and received at least one dose of study drug. For All Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
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