Trial Outcomes & Findings for Study of Obeldesivir in Nonhospitalized Participants With COVID-19 (NCT NCT05715528)
NCT ID: NCT05715528
Last Updated: 2024-12-24
Results Overview
The time to alleviation of targeted COVID-19 symptoms by Day 29 for participants with symptom alleviation, was calculated as symptom alleviation date/time minus first dose date/time. For participants who completed Day 29 of the study or discontinued from the study before Day 29 without symptom alleviation (censored) and without inter-current events, time was calculated as last date/time on which symptom alleviation was assessed minus the first dose date/time or Day 28, whichever occurred first. Symptom alleviation was defined as, all targeted symptoms scored moderate or severe at baseline were scored as mild/none and all targeted symptoms scored mild/none at baseline were scored as none, for at least 48 consecutive hours. Targeted symptoms included: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering and feeling hot or feverish. Kaplan-Meier (KM) estimates were used in outcome measure analysis.
COMPLETED
PHASE3
2011 participants
First dose date up to Day 29
2024-12-24
Participant Flow
2253 participants were screened.
Participants were enrolled at study sites in the United States and Japan.
Participant milestones
| Measure |
Obeldesivir
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Overall Study
STARTED
|
1005
|
1006
|
|
Overall Study
COMPLETED
|
977
|
963
|
|
Overall Study
NOT COMPLETED
|
28
|
43
|
Reasons for withdrawal
| Measure |
Obeldesivir
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Overall Study
Randomized but never treated
|
11
|
13
|
|
Overall Study
Withdrew consent
|
7
|
15
|
|
Overall Study
Lost to Follow-up
|
5
|
13
|
|
Overall Study
Investigator's discretion
|
3
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Non-compliance with study drug
|
0
|
1
|
Baseline Characteristics
Study of Obeldesivir in Nonhospitalized Participants With COVID-19
Baseline characteristics by cohort
| Measure |
Obeldesivir
n=979 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=976 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
Total
n=1955 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
960 Participants
n=5 Participants
|
961 Participants
n=7 Participants
|
1921 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
41 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
41 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
583 Participants
n=5 Participants
|
572 Participants
n=7 Participants
|
1155 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
396 Participants
n=5 Participants
|
404 Participants
n=7 Participants
|
800 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
918 Participants
n=5 Participants
|
901 Participants
n=7 Participants
|
1819 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
106 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
850 Participants
n=5 Participants
|
848 Participants
n=7 Participants
|
1698 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
962 Participants
n=5 Participants
|
962 Participants
n=7 Participants
|
1924 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load
|
5.08 log10 copies/mL
STANDARD_DEVIATION 1.416 • n=5 Participants
|
5.09 log10 copies/mL
STANDARD_DEVIATION 1.479 • n=7 Participants
|
5.09 log10 copies/mL
STANDARD_DEVIATION 1.448 • n=5 Participants
|
PRIMARY outcome
Timeframe: First dose date up to Day 29Population: The Full Analysis Positive Set (FAPS) included all participants, except from one of the site which did not comply with study rules, who were randomized into the study, have received at least 1 dose of study drug, and were SARS-CoV-2 positive at baseline as confirmed by Cepheid's Xpert Xpress CoV-2/Flu/RSV plus test or SARS-CoV-2 reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) test from central lab. Participants with available data were analyzed.
The time to alleviation of targeted COVID-19 symptoms by Day 29 for participants with symptom alleviation, was calculated as symptom alleviation date/time minus first dose date/time. For participants who completed Day 29 of the study or discontinued from the study before Day 29 without symptom alleviation (censored) and without inter-current events, time was calculated as last date/time on which symptom alleviation was assessed minus the first dose date/time or Day 28, whichever occurred first. Symptom alleviation was defined as, all targeted symptoms scored moderate or severe at baseline were scored as mild/none and all targeted symptoms scored mild/none at baseline were scored as none, for at least 48 consecutive hours. Targeted symptoms included: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering and feeling hot or feverish. Kaplan-Meier (KM) estimates were used in outcome measure analysis.
Outcome measures
| Measure |
Obeldesivir
n=879 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=882 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29
|
5.9 days
Interval 5.4 to 6.1
|
6.0 days
Interval 5.8 to 6.3
|
PRIMARY outcome
Timeframe: First dose date up to Day 5 plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
TEAEs were defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. * Any AEs leading to premature discontinuation of study drug. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=979 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=976 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
|
5.4 percentage of participants
|
5.7 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to Day 5 plus 30 daysPopulation: Participants from the Safety Analysis Set who had available postbaseline data were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=972 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=964 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Percentage of Participants Experiencing Laboratory Abnormalities
Any grade
|
77.5 percentage of participants
|
78.5 percentage of participants
|
|
Percentage of Participants Experiencing Laboratory Abnormalities
Grade 3 or 4
|
6.1 percentage of participants
|
8.5 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to Day 5 plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=979 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=976 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
SAEs
|
0.2 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
AEs leading to study drug discontinuation
|
0.1 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to 29Population: Participants in the Full Analysis Positive Set with available data were analyzed.
COVID-19 symptom resolution was defined as all targeted symptoms scored as none for at least 48 consecutive hours. The first day of the 48 consecutive hours was considered the date of symptom resolution. The time to COVID-19 symptom resolution was the time (expressed as days) from the first dose date/time to the date/time of symptom resolution. KM estimates were used in the outcome measure analysis.
Outcome measures
| Measure |
Obeldesivir
n=879 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=882 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Time to COVID-19 Symptom Resolution by Day 29
|
9.2 days
Interval 8.9 to 10.0
|
9.3 days
Interval 8.9 to 10.1
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Participants in the Full Analysis Positive Set who had short symptom recovery with available data were analyzed.
COVID-19 moderate symptom relapse was defined as having at least 1 symptom being moderate or severe OR at least 2 mild symptoms OR a hospitalization for COVID-19 or death, observed on a day during COVID-19 symptom relapse. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=760 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=743 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by Day 29
|
8.3 percentage of participants
Interval 6.4 to 10.5
|
9.0 percentage of participants
Interval 7.1 to 11.3
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Participants in the Full Analysis Positive Set were analyzed.
Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=884 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=884 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by Day 29
|
0.1 percentage of participants
Interval 0.0 to 0.3
|
0.2 percentage of participants
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Participants in the Full Analysis Positive Set were analyzed.
COVID-19-related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration (if there was 1 day difference between the start date and end date) of hospital admission, and primary reason for hospitalization (including if the hospitalization was related to COVID-19) was to be recorded. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=884 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=884 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 29
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 5Population: The Virology Analysis Set included all participants, who were randomized into the study, had received at least 1 dose of study drug, and had a baseline SARS-CoV-2 viral load ≥ Lower limit of quantification (LLOQ). Participants with available data were analyzed.
Outcome measures
| Measure |
Obeldesivir
n=637 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=622 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
|
-2.69 log10 copies/mL
Standard Error 0.019
|
-2.71 log10 copies/mL
Standard Error 0.020
|
SECONDARY outcome
Timeframe: Day 1 up to Day 29Population: The Antigen Analysis Set included all participants, who were randomized into the study, had received at least 1 dose of study drug, and had at least 1 SARS-CoV-2 rapid antigen test positive from Day 1 to Day 5 and SARS-CoV-2 polymerase chain reaction (PCR) positive at baseline per Full Analysis Positive Set.
Time to antigen negativity was defined (in days) as the number of days to the first date of 2 consecutive dates achieving a negative result. Antigen negativity was defined as 2 consecutive negative SARS-CoV-2 rapid antigen test (regardless if there was missing data in between), or negative test at last available sample for participants who completed or discontinued from the study after at least 1 positive antigen test.
Outcome measures
| Measure |
Obeldesivir
n=809 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=803 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Time to Antigen Negativity
|
5.0 days
Interval 3.0 to 6.0
|
5.0 days
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Participants from Antigen Analysis Set with antigen negativity were included.
Viral antigen rebound was defined as any positive SARS-CoV-2 rapid antigen test after antigen negativity. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=809 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=803 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Percentage of Participants With Viral Antigen Rebound
|
1.5 percentage of participants
Interval 0.8 to 2.6
|
1.7 percentage of participants
Interval 1.0 to 2.9
|
SECONDARY outcome
Timeframe: Day 1, 0.75 hour and 2 hours; Day 3, Predose and 0.75 hour; Day 5, Predose and 0.75 hourPopulation: The Pharmacokinetic (PK) Analysis Set included all randomized participants, who took at least 1 dose of study drug and had at least 1 non-missing concentration value reported by the PK laboratory for GS-441524. Participants with available data were analyzed.
Outcome measures
| Measure |
Obeldesivir
n=940 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Day 1 (0.75 h)
|
2528.97 ng/mL
Standard Deviation 5633.223
|
—
|
|
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Day 1 (2 h)
|
2390.68 ng/mL
Standard Deviation 4763.877
|
—
|
|
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Day 3 (Predose)
|
1103.79 ng/mL
Standard Deviation 6500.997
|
—
|
|
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Day 3 (0.75 h)
|
3339.59 ng/mL
Standard Deviation 11353.578
|
—
|
|
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Day 5 (Predose)
|
2599.61 ng/mL
Standard Deviation 29678.065
|
—
|
|
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Day 5 (0.75 h)
|
4595.37 ng/mL
Standard Deviation 30772.089
|
—
|
SECONDARY outcome
Timeframe: Day 5Population: The Intensive PK Substudy analysis set included all randomized participants, who took at least 1 dose of study drug, participated in the intensive PK substudy, and had at least 1 non-missing concentration for GS-441524, excluding participants with identified outliers, were analyzed.
AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady-state.
Outcome measures
| Measure |
Obeldesivir
n=63 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Pharmacokinetic (PK) Parameter: AUCtau,Steady-State of GS-441524
|
18000 h*ng/mL
Standard Deviation 10200
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 5Population: Participants from Intensive PK Substudy Analysis Set excluding participants with identified outliers, were analyzed.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Outcome measures
| Measure |
Obeldesivir
n=64 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
PK Parameter: Ctau of GS-441524
Day 1
|
772 ng/mL
Standard Deviation 761
|
—
|
|
PK Parameter: Ctau of GS-441524
Day 5
|
735 ng/mL
Standard Deviation 919
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 5Population: Participants from Intensive PK Substudy Analysis Set excluding participants with identified outliers, were analyzed.
Cmax is defined as the maximum observed plasma concentration of drug.
Outcome measures
| Measure |
Obeldesivir
n=99 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
PK Parameter: Cmax of GS-441524
Day 1
|
2910 ng/mL
Standard Deviation 1010
|
—
|
|
PK Parameter: Cmax of GS-441524
Day 5
|
2920 ng/mL
Standard Deviation 1220
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Participants in the Full Analysis Positive Set with available data were analyzed.
Symptom relapse means at least 2 consecutive diary entries (regardless of missing data in between) where there was any symptom (regardless of severity) OR a hospitalization for COVID-19 or a death after short symptom recovery. Percentages were rounded off.
Outcome measures
| Measure |
Obeldesivir
n=760 Participants
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=743 Participants
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Percentage of Participants With Relapse of COVID-19 Symptoms by Day 29
|
10.9 percentage of participants
Interval 8.8 to 13.4
|
12.0 percentage of participants
Interval 9.7 to 14.5
|
Adverse Events
Obeldesivir
Placebo
Serious adverse events
| Measure |
Obeldesivir
n=979 participants at risk
Participants received obeldesivir 350 mg orally twice daily without regard to food for 5 days.
|
Placebo
n=976 participants at risk
Participants received placebo-to-match obeldesivir orally twice daily without regard to food for 5 days.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis bacterial
|
0.10%
1/979 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
0.00%
0/976 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/979 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
0.10%
1/976 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/979 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
0.10%
1/976 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.10%
1/979 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
0.00%
0/976 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/979 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
0.10%
1/976 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
|
Vascular disorders
Hypertension
|
0.00%
0/979 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
0.10%
1/976 • Adverse Events and All-Cause Mortality: Up to 35 days
All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: The Safety Analysis Set included all participants, who were randomized into the study and have received at least 1 dose of study drug, except from one of the site which did not comply with study rules.
|
Other adverse events
Adverse event data not reported
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER