Trial Outcomes & Findings for Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (NCT NCT02362503)
NCT ID: NCT02362503
Last Updated: 2025-08-22
Results Overview
Plasma samples were collected for analysis of HIV-1 RNA. Mean change in log10 HIV-1 RNA from Day 1 was estimated using analysis of covariance (ANCOVA) with log10 HIV-1 RNA change from Day 1 at Day 8 as dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 log10 HIV-1 RNA as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. The analysis was performed on Intent-to-Treat Exposed (ITT-E) Population which comprised of all randomized participants who received at least one dose of study treatment. Missing HIV-1 RNA values at Day 8 were imputed using (a) Day 1 Observation Carried Forward (D1OCF) for participants without a value during blinded treatment (i.e, imputing a zero change from Day 1) or (b) Last Observation Carried Forward (LOCF) for participants with an early value during blinded treatment before the Day 8 analysis visit window.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
371 participants
Primary outcome timeframe
Day 1 and Day 8
Results posted on
2025-08-22
Participant Flow
This was a 2 cohort Phase 3 study conducted in heavily treatment experienced (HTE) participants infected with multi-drug resistant human immunodeficiency virus (HIV)-1. Participants were assigned to either the Randomized Cohort (participants received either fostemsavir or placebo) or Non-randomized Cohort (all participants received fostemsavir).
A total of 731 participants were screened, of which 371 were included in either Randomized Cohort or Non-randomized Cohort and received at least one dose of study treatment. The results presented are based on Week 96 interim analysis. Data collection is still on-going and additional results will be provided after study completion.
Participant milestones
| Measure |
Randomized Cohort-Placebo
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
Non-randomized Cohort-fostemsavir 600 mg BID-Open Label Period
Eligible participants in the Non-randomized Cohort had zero remaining fully active and approved antiretroviral regimens at Baseline. Participants received fostemsavir 600 mg BID in combination with OBT.
|
|---|---|---|---|
|
Double-blind Period-Up to 8 Days
STARTED
|
69
|
203
|
0
|
|
Double-blind Period-Up to 8 Days
COMPLETED
|
68
|
199
|
0
|
|
Double-blind Period-Up to 8 Days
NOT COMPLETED
|
1
|
4
|
0
|
|
Open Label Period-Up to 96 Weeks
STARTED
|
68
|
199
|
99
|
|
Open Label Period-Up to 96 Weeks
COMPLETED
|
0
|
0
|
0
|
|
Open Label Period-Up to 96 Weeks
NOT COMPLETED
|
68
|
199
|
99
|
Reasons for withdrawal
| Measure |
Randomized Cohort-Placebo
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
Non-randomized Cohort-fostemsavir 600 mg BID-Open Label Period
Eligible participants in the Non-randomized Cohort had zero remaining fully active and approved antiretroviral regimens at Baseline. Participants received fostemsavir 600 mg BID in combination with OBT.
|
|---|---|---|---|
|
Double-blind Period-Up to 8 Days
Adverse Event
|
0
|
2
|
0
|
|
Double-blind Period-Up to 8 Days
Death
|
1
|
0
|
0
|
|
Double-blind Period-Up to 8 Days
Lost to Follow-up
|
0
|
1
|
0
|
|
Double-blind Period-Up to 8 Days
No longer meets study criteria
|
0
|
1
|
0
|
|
Open Label Period-Up to 96 Weeks
Other
|
0
|
1
|
1
|
|
Open Label Period-Up to 96 Weeks
No longer meets criteria
|
0
|
4
|
4
|
|
Open Label Period-Up to 96 Weeks
Pregnancy
|
0
|
1
|
0
|
|
Open Label Period-Up to 96 Weeks
Non-compliance with study drug
|
3
|
8
|
6
|
|
Open Label Period-Up to 96 Weeks
Lost to Follow-up
|
4
|
3
|
1
|
|
Open Label Period-Up to 96 Weeks
Death
|
1
|
7
|
15
|
|
Open Label Period-Up to 96 Weeks
Withdrawal by Subject
|
0
|
5
|
1
|
|
Open Label Period-Up to 96 Weeks
Adverse Event
|
3
|
2
|
4
|
|
Open Label Period-Up to 96 Weeks
Lack of Efficacy
|
3
|
9
|
6
|
|
Open Label Period-Up to 96 Weeks
Ongoing at the time of analysis
|
54
|
159
|
61
|
Baseline Characteristics
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
Baseline characteristics by cohort
| Measure |
Randomized Cohort-Placebo
n=69 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
n=203 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
Non-randomized Cohort-fostemsavir 600 mg BID-Open Label Period
n=99 Participants
Eligible participants in the Non-randomized Cohort had zero remaining fully active and approved antiretroviral regimens at Baseline. Participants received fostemsavir 600 mg BID in combination with OBT.
|
Total
n=371 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.0 Years
STANDARD_DEVIATION 11.02 • n=5 Participants
|
45.2 Years
STANDARD_DEVIATION 12.72 • n=7 Participants
|
48.1 Years
STANDARD_DEVIATION 11.53 • n=5 Participants
|
45.6 Years
STANDARD_DEVIATION 12.20 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
289 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Black or African American
|
18 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Native Hawaiian or other Pacific islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · White
|
48 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Mixed
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Hispanic
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Mestizo
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · North African
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Mulatto
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · Brown
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race customized · White and African descent
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 8Population: ITT-E Population. Participants with missing Day 1 HIV-1 RNA values were not analyzed.
Plasma samples were collected for analysis of HIV-1 RNA. Mean change in log10 HIV-1 RNA from Day 1 was estimated using analysis of covariance (ANCOVA) with log10 HIV-1 RNA change from Day 1 at Day 8 as dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 log10 HIV-1 RNA as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. The analysis was performed on Intent-to-Treat Exposed (ITT-E) Population which comprised of all randomized participants who received at least one dose of study treatment. Missing HIV-1 RNA values at Day 8 were imputed using (a) Day 1 Observation Carried Forward (D1OCF) for participants without a value during blinded treatment (i.e, imputing a zero change from Day 1) or (b) Last Observation Carried Forward (LOCF) for participants with an early value during blinded treatment before the Day 8 analysis visit window.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=69 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
n=201 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort
|
-0.166 Log10 copies per milliliter (c/mL)
Interval -0.326 to -0.007
|
-0.791 Log10 copies per milliliter (c/mL)
Interval -0.885 to -0.698
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: ITT-E Population
The percentage of participants in the Randomized Cohort with HIV-1 RNA decreases from Day 1 that exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8 was determined by comparing HIV-1 RNA Day 1 measurement of each participant to their Day 8 measurement. This was an ITT analysis that classified participants without HIV-1 RNA at Day 1 or Day 8 as failures. The percentage of responders along with 95% confidence interval based on Wilson score is presented.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=69 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
n=203 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort
>0.5 log10 c/mL
|
18.84 Percentage of participants
Interval 11.35 to 29.61
|
64.53 Percentage of participants
Interval 57.74 to 70.79
|
|
Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort
>1.0 log10 c/mL
|
10.14 Percentage of participants
Interval 5.0 to 19.49
|
45.81 Percentage of participants
Interval 39.1 to 52.68
|
SECONDARY outcome
Timeframe: At Weeks 24, 48 and 96Population: ITT-E Population
The durability of response (that is, the number of participants achieving HIV-1 RNA \<40 c/mL) at Weeks 24, 48 and 96 of open-label fostemsavir plus OBT in the Randomized Cohort was assessed using the Food and Drug Administration (FDA) snapshot algorithm in which participants without HIV-1 RNA at Weeks 24, 48 and 96 or those who changed OBT due to lack of efficacy through Weeks 24, 48 and 96 were counted as failures. The percentage of participants in the Randomized Cohort who achieved virologic success (HIV-1 RNA \<40 c/mL) at Weeks 24, 48 and 96 is presented along with 95% Wilson confidence interval. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=272 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24, 48 and 96-Randomized Cohort
Week 24
|
53 Percentage of participants
Interval 47.0 to 58.8
|
—
|
|
Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24, 48 and 96-Randomized Cohort
Week 48
|
54 Percentage of participants
Interval 47.7 to 59.5
|
—
|
|
Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24, 48 and 96-Randomized Cohort
Week 96
|
60 Percentage of participants
Interval 54.0 to 65.6
|
—
|
SECONDARY outcome
Timeframe: Up to Week 96 analysis cut-off datePopulation: Safety Population.
An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; an important medical event that may jeopardize the participant or require intervention. Number of participants with on-treatment SAEs and AEs leading to withdrawal of study treatment is presented. SAEs and AELDs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=272 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Randomized Cohort
SAE
|
92 Participants
|
—
|
|
Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Randomized Cohort
AELD
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Week 96 analysis cut-off datePopulation: Safety Population. Only participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Laboratory toxicities were graded for severity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with clinical chemistry toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=272 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Albumin; n=268
|
1 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Alkaline phosphatase; n=268
|
3 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Alanine aminotransferase; n=268
|
14 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Amylase; n=268
|
2 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Aspartate aminotransferase; n=268
|
10 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Bicarbonate; n=268
|
1 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Direct bilirubin; n=268
|
20 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Bilirubin; n=268
|
7 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Calcium; n=268
|
9 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Cholesterol; n=221
|
10 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Creatine kinase; n=268
|
6 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Creatinine; n=268
|
52 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Estimated creatinine clearance; n=268
|
75 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Glucose/hyperglycemia; n=267
|
6 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Glucose/hypoglycemia; n=267
|
2 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Potassium/hyperkalemia; n=268
|
4 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Potassium/hypokalemia; n=268
|
0 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Low density lipoprotein (LDL) cholesterol; n=216
|
8 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Lipase; n=268
|
13 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Sodium/hypernatremia; n=268
|
0 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Sodium/hyponatremia; n=268
|
0 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Triglycerides; n=221
|
11 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Urate; n=268
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Week 96 analysis cut-off datePopulation: Safety Population. Only participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Laboratory toxicities were graded for severity according to the DAIDS grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with hematology toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=272 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Hemoglobin; n=268
|
16 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Neutrophils; n=268
|
10 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Platelets; n=267
|
2 Participants
|
—
|
|
Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Leukocytes; n=268
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 96 analysis cut-off datePopulation: Safety Population
Disease progression during open label fostemsavir plus OBT was assessed based on the occurrence of new AIDS defining events (CDC Class C events) or death. The number of participants with on-treatment CDC Class C AIDS events is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=272 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Number of Participants With Centers for Disease Control (CDC) Class C Events-Randomized Cohort
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell counts from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an in-dependent variable, and Day 1 CD4+ cell count as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (i.e., imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=69 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
n=196 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Change From Day 1 in Cluster of Differentiation (CD) 4+ T-cell Count at Day 8-Randomized Cohort
|
18.9 Cells per cubic millimeter
Interval 4.7 to 33.0
|
18.5 Cells per cubic millimeter
Interval 10.1 to 26.8
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed.
CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count percentage from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell count percentage from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 CD4+ cell count percentage as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (ie, imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=69 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
n=196 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Change in CD4+ T- Cell Count Percentage From Day 1 at Day 8-Randomized Cohort
|
0.243 Percentage of CD4+T- cells
Interval -0.216 to 0.703
|
0.860 Percentage of CD4+T- cells
Interval 0.588 to 1.133
|
SECONDARY outcome
Timeframe: Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Blood samples were collected for the analysis of HIV-1 RNA. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=272 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Day 8; n=262
|
-0.656 Log10 c/mL
Standard Deviation 0.7536
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 4; n=262
|
-2.051 Log10 c/mL
Standard Deviation 1.0717
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 8; n=256
|
-2.207 Log10 c/mL
Standard Deviation 1.1416
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 12; n=248
|
-2.237 Log10 c/mL
Standard Deviation 1.2105
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 16; n=249
|
-2.277 Log10 c/mL
Standard Deviation 1.2834
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 24; n=246
|
-2.297 Log10 c/mL
Standard Deviation 1.2788
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 36; n=238
|
-2.332 Log10 c/mL
Standard Deviation 1.2265
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 48; n=233
|
-2.324 Log10 c/mL
Standard Deviation 1.2876
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 60; n=223
|
-2.419 Log10 c/mL
Standard Deviation 1.1973
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 72; n=221
|
-2.427 Log10 c/mL
Standard Deviation 1.1542
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 84; n=215
|
-2.455 Log10 c/mL
Standard Deviation 1.1930
|
—
|
|
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Week 96; n=214
|
-2.476 Log10 c/mL
Standard Deviation 1.1984
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=272 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Day 8; n=255
|
19.8 Cells per cubic millimeter
Standard Deviation 60.98
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 4; n=259
|
48.9 Cells per cubic millimeter
Standard Deviation 131.75
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 8; n=254
|
61.5 Cells per cubic millimeter
Standard Deviation 113.47
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 12; n=249
|
79.0 Cells per cubic millimeter
Standard Deviation 123.31
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 16; n=245
|
84.1 Cells per cubic millimeter
Standard Deviation 107.26
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 24; n=247
|
90.4 Cells per cubic millimeter
Standard Deviation 112.10
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 36; n=234
|
109.7 Cells per cubic millimeter
Standard Deviation 119.50
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 48; n=228
|
138.9 Cells per cubic millimeter
Standard Deviation 135.06
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 60; n=215
|
162.9 Cells per cubic millimeter
Standard Deviation 157.69
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 72; n=217
|
172.1 Cells per cubic millimeter
Standard Deviation 184.81
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 84; n=203
|
190.8 Cells per cubic millimeter
Standard Deviation 165.63
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Week 96; n=213
|
204.7 Cells per cubic millimeter
Standard Deviation 191.28
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Percentage CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=272 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Day 8; n=255
|
0.75 Percentage of CD4+ T- cells
Standard Deviation 1.970
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 4; n=259
|
2.30 Percentage of CD4+ T- cells
Standard Deviation 4.643
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 8; n=254
|
2.36 Percentage of CD4+ T- cells
Standard Deviation 4.392
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 12; n=249
|
3.00 Percentage of CD4+ T- cells
Standard Deviation 4.945
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 16; n=245
|
3.51 Percentage of CD4+ T- cells
Standard Deviation 4.979
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 24; n=247
|
4.26 Percentage of CD4+ T- cells
Standard Deviation 4.828
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 36; n=234
|
5.06 Percentage of CD4+ T- cells
Standard Deviation 5.256
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 48; n=228
|
6.51 Percentage of CD4+ T- cells
Standard Deviation 5.531
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 60; n=215
|
7.00 Percentage of CD4+ T- cells
Standard Deviation 5.940
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 72; n=217
|
7.02 Percentage of CD4+ T- cells
Standard Deviation 5.726
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 84; n=203
|
7.68 Percentage of CD4+ T- cells
Standard Deviation 5.798
|
—
|
|
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Week 96; n=213
|
8.44 Percentage of CD4+ T- cells
Standard Deviation 6.409
|
—
|
SECONDARY outcome
Timeframe: Week 96Population: PDVF through Week 96 Population. Only participants available at the specified time point were analyzed.
Plasma samples were collected for emergent drug resistance testing. The number of participants with emergent viral genotypic substitutions of interest in the GP160 domain was identified by the next-generation sequencing (NGS) assay. Protocol defined virologic failure (PDVF) through Week 96 Population comprised of all participants with available phenotypic and genotypic resistance data meeting at the time protocol defined virologic failure (PDVF) was met. The criteria for PDVF was a) Confirmed, or last available prior to discontinuation, HIV-1 RNA \>=400 c/mL at any time after prior confirmed suppression to \<400 c/mL prior to Week 24 or Confirmed, or last available prior to discontinuation, \> 1 log10 c/mL increase in HIV-1 RNA at any time above nadir level where nadir is \>=40 c/mL prior to Week 24. b) Confirmed, or last available prior to discontinuation, HIV-1 RNA \>=400 c/mL at or after Week 24.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=50 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Viral Genotypic Substitution of Interest in the GP160 Domain as a Measure of Genotypic Resistance-Randomized Cohort
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 96Population: PDVF through Week 96 Population. Only participants available at the specified time point were analyzed.
The phenotypic resistance to a drug is defined in terms of a fold change (FC) in IC50s, i.e., the ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of a reference strain (wild type control). FCR was calculated as FC at PDVF divided by Baseline FC. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. FCR\<1 indicates that FC is smaller on-treatment than at Baseline. FCR \>3 indicates that on-treatment FC is 3 times greater than it was at Baseline.
Outcome measures
| Measure |
Randomized Cohort-Placebo
n=53 Participants
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
|---|---|---|
|
Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort
<=1
|
19 Participants
|
—
|
|
Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort
>1 to 3
|
10 Participants
|
—
|
|
Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort
>3 to 10
|
5 Participants
|
—
|
|
Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort
>10 to 100
|
1 Participants
|
—
|
|
Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort
>100 to 3000
|
10 Participants
|
—
|
|
Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort
>3000
|
8 Participants
|
—
|
Adverse Events
Randomized Cohort-Placebo
Serious events: 2 serious events
Other events: 16 other events
Deaths: 2 deaths
Randomized Cohort-fostemsavir 600 mg BID
Serious events: 4 serious events
Other events: 45 other events
Deaths: 10 deaths
Non-randomized Cohort-fostemsavir 600 mg BID
Serious events: 48 serious events
Other events: 92 other events
Deaths: 17 deaths
Randomized Cohort-Total
Serious events: 92 serious events
Other events: 214 other events
Deaths: 12 deaths
Total Fostemsavir
Serious events: 140 serious events
Other events: 306 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Randomized Cohort-Placebo
n=69 participants at risk
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
n=203 participants at risk
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
Non-randomized Cohort-fostemsavir 600 mg BID
n=99 participants at risk
This reporting group includes HTE HIV-1 infected participants who were assigned to the Non-randomized Cohort and received fostemsavir 600 mg BID and OBT. Non-randomized Cohort participants are assigned based on their screening status of having no remaining classes of fully active antiretroviral that can combined in a new drug regimen. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
|
Randomized Cohort-Total
n=271 participants at risk
This reporting group includes all participants in the Randomized Cohort. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
|
Total Fostemsavir
n=370 participants at risk
This reporting group included all enrolled participants (Randomized Cohort and Non-randomized Cohort) and who received fostemsavir 600 mg during the open-label period. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.99%
2/203 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
3/99 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.4%
12/271 • Number of events 15 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.1%
15/370 • Number of events 19 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
3/99 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.8%
5/271 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.2%
8/370 • Number of events 9 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.0%
4/99 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.6%
6/370 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
3/271 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
4/370 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
3/271 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
4/370 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.5%
4/271 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
4/370 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
3/99 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
4/370 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
3/271 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
4/370 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
3/99 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
4/370 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Sepsis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
3/99 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
4/370 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
3/271 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.81%
3/370 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.81%
3/370 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.0%
2/99 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.81%
3/370 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
Pyrexia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.0%
2/99 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.81%
3/370 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Seizure
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.0%
2/99 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.81%
3/370 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.81%
3/370 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
Asthenia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.0%
2/99 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.0%
2/99 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.49%
1/203 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
HIV-associated neurocognitive disorder
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.0%
2/99 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile squamous cell carcinoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.0%
2/99 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Septic shock
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.54%
2/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Anorectal cellulitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Injury, poisoning and procedural complications
Arterial bypass thrombosis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Investigations
Blood HIV RNA increased
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Central nervous system immune reconstitution inflammatory response
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
Chest pain
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma recurrent
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Disseminated cytomegaloviral infection
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
Facial pain
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
General physical health deterioration
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
Generalised oedema
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Headache
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Hepatitis B reactivation
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Histoplasmosis disseminated
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Influenza
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Injury, poisoning and procedural complications
Kidney rupture
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage IV
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Meningitis coccidioides
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Meningoencephalitis viral
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Mononeuropathy
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Oesophagitis
|
1.4%
1/69 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Orchitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Prostatic abscess
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Reactive gastropathy
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Salmonella bacteraemia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.49%
1/203 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Septic rash
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Investigations
Transaminases increased
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Tremor
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Tuberculosis liver
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.0%
1/99 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.27%
1/370 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
1/69 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/370 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Metabolism and nutrition disorders
Cachexia
|
1.4%
1/69 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/99 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/271 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/370 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
Other adverse events
| Measure |
Randomized Cohort-Placebo
n=69 participants at risk
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
|
Randomized Cohort-fostemsavir 600 mg BID
n=203 participants at risk
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
|
Non-randomized Cohort-fostemsavir 600 mg BID
n=99 participants at risk
This reporting group includes HTE HIV-1 infected participants who were assigned to the Non-randomized Cohort and received fostemsavir 600 mg BID and OBT. Non-randomized Cohort participants are assigned based on their screening status of having no remaining classes of fully active antiretroviral that can combined in a new drug regimen. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
|
Randomized Cohort-Total
n=271 participants at risk
This reporting group includes all participants in the Randomized Cohort. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
|
Total Fostemsavir
n=370 participants at risk
This reporting group included all enrolled participants (Randomized Cohort and Non-randomized Cohort) and who received fostemsavir 600 mg during the open-label period. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
3/69 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.9%
8/203 • Number of events 8 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
25.3%
25/99 • Number of events 48 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
22.1%
60/271 • Number of events 84 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
23.0%
85/370 • Number of events 132 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
4/69 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.9%
14/203 • Number of events 14 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
21.2%
21/99 • Number of events 31 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
16.6%
45/271 • Number of events 65 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
17.8%
66/370 • Number of events 96 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.49%
1/203 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
15.2%
15/99 • Number of events 21 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
15.5%
42/271 • Number of events 64 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
15.4%
57/370 • Number of events 85 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.99%
2/203 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
19.2%
19/99 • Number of events 24 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
12.5%
34/271 • Number of events 50 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
14.3%
53/370 • Number of events 74 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Headache
|
7.2%
5/69 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
6/203 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
12.1%
12/99 • Number of events 13 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
13.3%
36/271 • Number of events 53 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
13.0%
48/370 • Number of events 66 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
Pyrexia
|
1.4%
1/69 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.49%
1/203 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
16.2%
16/99 • Number of events 24 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
11.1%
30/271 • Number of events 42 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
12.4%
46/370 • Number of events 66 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/69 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
11.1%
11/99 • Number of events 12 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
12.2%
33/271 • Number of events 45 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
11.9%
44/370 • Number of events 57 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 7 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
12.5%
34/271 • Number of events 45 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
10.5%
39/370 • Number of events 52 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Influenza
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.49%
1/203 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
13.1%
13/99 • Number of events 15 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
9.6%
26/271 • Number of events 31 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
10.5%
39/370 • Number of events 46 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.99%
2/203 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
9.1%
9/99 • Number of events 13 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
10.7%
29/271 • Number of events 48 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
10.3%
38/370 • Number of events 61 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
Fatigue
|
2.9%
2/69 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.5%
3/203 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
16.2%
16/99 • Number of events 16 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.6%
18/271 • Number of events 19 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
9.2%
34/370 • Number of events 35 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
11.1%
11/99 • Number of events 13 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
8.1%
22/271 • Number of events 29 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
8.9%
33/370 • Number of events 42 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
9.1%
9/99 • Number of events 11 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
8.1%
22/271 • Number of events 24 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
8.4%
31/370 • Number of events 35 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.5%
3/203 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.1%
6/99 • Number of events 7 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
8.5%
23/271 • Number of events 23 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
7.8%
29/370 • Number of events 30 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/69 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
12.1%
12/99 • Number of events 14 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.9%
16/271 • Number of events 18 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
7.6%
28/370 • Number of events 32 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.5%
3/203 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
8.1%
22/271 • Number of events 30 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
7.3%
27/370 • Number of events 35 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.49%
1/203 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
10.1%
10/99 • Number of events 13 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.3%
17/271 • Number of events 21 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
7.3%
27/370 • Number of events 34 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
10.1%
10/99 • Number of events 14 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.5%
15/271 • Number of events 17 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.8%
25/370 • Number of events 31 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
General disorders
Asthenia
|
2.9%
2/69 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.99%
2/203 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
12.1%
12/99 • Number of events 13 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.1%
11/271 • Number of events 14 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.2%
23/370 • Number of events 27 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/69 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.99%
2/203 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.3%
17/271 • Number of events 18 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.9%
22/370 • Number of events 23 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
3/99 • Number of events 3 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.6%
18/271 • Number of events 20 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.7%
21/370 • Number of events 23 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
7.1%
7/99 • Number of events 7 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.2%
14/271 • Number of events 16 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.7%
21/370 • Number of events 23 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/69 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.99%
2/203 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.0%
2/99 • Number of events 2 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.3%
17/271 • Number of events 19 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
19/370 • Number of events 21 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.4%
12/271 • Number of events 16 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.6%
17/370 • Number of events 22 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.49%
1/203 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.1%
6/99 • Number of events 8 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.1%
11/271 • Number of events 11 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.6%
17/370 • Number of events 19 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.1%
6/99 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.1%
11/271 • Number of events 15 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.6%
17/370 • Number of events 21 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.1%
11/271 • Number of events 12 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
4.3%
16/370 • Number of events 17 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
8.1%
8/99 • Number of events 9 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.2%
6/271 • Number of events 7 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.8%
14/370 • Number of events 16 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Onychomycosis
|
1.4%
1/69 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.1%
6/99 • Number of events 8 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
8/271 • Number of events 8 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.8%
14/370 • Number of events 16 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.1%
6/99 • Number of events 8 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
8/271 • Number of events 8 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.8%
14/370 • Number of events 16 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.1%
6/99 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.8%
5/271 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
11/370 • Number of events 12 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.49%
1/203 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.2%
6/271 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
11/370 • Number of events 11 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.2%
6/271 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
3.0%
11/370 • Number of events 11 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.5%
4/271 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.4%
9/370 • Number of events 9 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.5%
4/271 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.4%
9/370 • Number of events 9 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.5%
4/271 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.4%
9/370 • Number of events 10 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/69 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.1%
3/271 • Number of events 4 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
2.2%
8/370 • Number of events 10 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
6.1%
6/99 • Number of events 6 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.37%
1/271 • Number of events 1 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.9%
7/370 • Number of events 7 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/69 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.00%
0/203 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
5.1%
5/99 • Number of events 5 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
0.74%
2/271 • Number of events 15 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
1.9%
7/370 • Number of events 20 • On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER