Trial Outcomes & Findings for Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors (NCT NCT03954704)
NCT ID: NCT03954704
Last Updated: 2023-11-21
Results Overview
DLT was defined as: Grade 3 thrombocytopenia with bleeding; Grade ≥ 3 febrile neutropenia; any Grade 4 hematologic laboratory abnormalities/adverse events (AEs) (except Grade 4 lymphopenia and anaemia, Grade 4 neutropenia lasting ≤ 7 days with no fever); Grade 4 non-hematologic AEs; any ≥Grade 2 uveitis, blurred vision, eye pain, and/or reduction of visual acuity that did not respond to topical therapy and did not improve to Grade 1 severity within 2 weeks of topical therapy initiation or required systemic treatment; Grade 3 non-hematologic AEs; any other non-immune-related Grade 3 AE (except any Grade 3 endocrinopathy; Grade 3 AE of tumor flare; transient \[≤ 3 days\] Grade 3 fatigue, local reactions, headache, nausea, emesis, or diarrhea and/or resolved to Grade ≤ 1; transient Grade 3 flu-like symptoms or fever); inability to receive first 2 doses of GS-1423 or \> 2-week delay in starting next cycle of therapy due to a treatment-related toxicity; Grade 5 event (death).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Baseline up to 28 days
Results posted on
2023-11-21
Participant Flow
Participants were enrolled at study sites in United States. The first participant was screened on 03 June 2019. The last study visit occurred on 15 April 2021.
The study was discontinued prior to initiation of Phase 1a Part B and Phase 1b. Therefore, data are reported for only Phase 1a Part A.
Participant milestones
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
GS-1423 0.3 mg/kg of body weight, solution for intravenous (IV) infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
3
|
3
|
3
|
8
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
3
|
3
|
8
|
3
|
Reasons for withdrawal
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
GS-1423 0.3 mg/kg of body weight, solution for intravenous (IV) infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
1
|
3
|
2
|
2
|
0
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
1
|
0
|
1
|
4
|
2
|
|
Overall Study
Enrolled but not Treated
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
n=1 Participants
GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
n=1 Participants
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
n=3 Participants
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
n=3 Participants
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
n=3 Participants
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
n=7 Participants
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
n=3 Participants
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=39 Participants
|
67 years
n=41 Participants
|
70 years
STANDARD_DEVIATION 8.7 • n=35 Participants
|
70 years
STANDARD_DEVIATION 11.6 • n=31 Participants
|
62 years
STANDARD_DEVIATION 7.4 • n=146 Participants
|
57 years
STANDARD_DEVIATION 15.8 • n=19 Participants
|
71 years
STANDARD_DEVIATION 7.2 • n=147 Participants
|
64 years
STANDARD_DEVIATION 12.0 • n=193 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
15 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=147 Participants
|
6 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
5 Participants
n=19 Participants
|
2 Participants
n=147 Participants
|
14 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
4 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
3 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
3 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
5 Participants
n=19 Participants
|
3 Participants
n=147 Participants
|
18 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 daysPopulation: The DLT-Evaluable Analysis Set included all participants who were enrolled for dose escalation, received the protocol-specified treatment, and completed safety procedures through Day 28 (inclusive) or experienced a DLT prior to Day 28.
DLT was defined as: Grade 3 thrombocytopenia with bleeding; Grade ≥ 3 febrile neutropenia; any Grade 4 hematologic laboratory abnormalities/adverse events (AEs) (except Grade 4 lymphopenia and anaemia, Grade 4 neutropenia lasting ≤ 7 days with no fever); Grade 4 non-hematologic AEs; any ≥Grade 2 uveitis, blurred vision, eye pain, and/or reduction of visual acuity that did not respond to topical therapy and did not improve to Grade 1 severity within 2 weeks of topical therapy initiation or required systemic treatment; Grade 3 non-hematologic AEs; any other non-immune-related Grade 3 AE (except any Grade 3 endocrinopathy; Grade 3 AE of tumor flare; transient \[≤ 3 days\] Grade 3 fatigue, local reactions, headache, nausea, emesis, or diarrhea and/or resolved to Grade ≤ 1; transient Grade 3 flu-like symptoms or fever); inability to receive first 2 doses of GS-1423 or \> 2-week delay in starting next cycle of therapy due to a treatment-related toxicity; Grade 5 event (death).
Outcome measures
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
n=1 Participants
GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
n=1 Participants
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
n=3 Participants
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
n=3 Participants
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
n=3 Participants
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
n=5 Participants
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
n=3 Participants
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Phase 1a Part A: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs), Graded Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 daysPopulation: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
An AE was any untoward medical occurrence in a participant administered the study drug, which did not necessarily have a causal relationship with the treatment. An AE could therefore, be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Adverse events might also include pretreatment or posttreatment complications that occurred as a result of protocol-specified procedures or special situations. Preexisting events that increased in severity or change in nature during or as a consequence of participation in the study were also considered AEs. TEAEs were AEs with onset dates on or after the first dose of study drug GS-1423 and up to 30 days after permanent withdrawal of GS-1423.
Outcome measures
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
n=1 Participants
GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
n=1 Participants
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
n=3 Participants
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
n=3 Participants
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
n=3 Participants
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
n=7 Participants
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
n=3 Participants
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Phase 1a Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
Severity was graded per NCI CTCAE v5.0. Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, Grade 5: Death related to AE.
Outcome measures
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
n=1 Participants
GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
n=1 Participants
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
n=3 Participants
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
n=3 Participants
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
n=3 Participants
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
n=7 Participants
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
n=3 Participants
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Phase 1a Part A: Percentage of Participants With Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities
Hematology
|
0 percentage of participants
|
100.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities
Serum Chemistry
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities
Coagulation
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities
Endocrine Function Tests
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Treatment-Emergent Grade 3 or 4 Laboratory Abnormalities
Urinalysis
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to permanent withdrawal of GS-1423 (maximum duration: 26.3 weeks) plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
The Baseline value was the last available value collected on or prior to first dose of study drug. Percentages were based on participants with values available at both baseline and postbaseline. NCS = Non-clinical significance; CS = Clinical significance.
Outcome measures
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
n=1 Participants
GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
n=1 Participants
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
n=3 Participants
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
n=3 Participants
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
n=3 Participants
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
n=7 Participants
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
n=3 Participants
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study
Normal baseline - Normal
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study
Normal baseline - Abnormal NCS
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
71.4 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study
Normal baseline - Abnormal CS
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study
Abnormal NCS Baseline - Normal
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study
Abnormal NCS Baseline - Abnormal NCS
|
100.0 percentage of participants
|
100.0 percentage of participants
|
66.7 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
28.6 percentage of participants
|
100.0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study
Abnormal NCS Baseline - Abnormal CS
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study
Abnormal CS Baseline - Normal
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study
Abnormal CS Baseline - Abnormal NCS
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants With Shift in Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) From Baseline to Overall Study
Abnormal CS Baseline - Abnormal CS
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 4: Day 1 (Predose, end of infusion, 2 and 6 hours post start of infusion); Days 2, 3, 5, and 8 (additionally at Day 15 in Cycle 4)Population: Participants in the PK Analysis Set (all enrolled participants who received at least 1 dose of study drug and had at least 1 non-missing postdose concentration value reported by the PK laboratory) with available data were analyzed.
AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
n=3 Participants
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
n=3 Participants
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
n=3 Participants
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
n=6 Participants
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
n=3 Participants
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Phase 1a Part A: Pharmacokinetic (PK) Parameter: AUCtau of GS-1423
Cycle 1
|
—
|
—
|
1476.9 µg*h/mL
Standard Deviation 759.84
|
5311.8 µg*h/mL
Standard Deviation 595.77
|
33530.9 µg*h/mL
Standard Deviation 1646.22
|
51593.2 µg*h/mL
Standard Deviation 16313.20
|
64856.3 µg*h/mL
Standard Deviation 9814.95
|
|
Phase 1a Part A: Pharmacokinetic (PK) Parameter: AUCtau of GS-1423
Cycle 4
|
—
|
—
|
1711.9 µg*h/mL
Standard Deviation 1486.08
|
—
|
28558.0 µg*h/mL
|
65368.1 µg*h/mL
Standard Deviation 5469.82
|
74097.0 µg*h/mL
|
SECONDARY outcome
Timeframe: Baseline, during the treatment (maximum duration: 26.3 weeks), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 4 Day 15, Cycle 6 Day 1, 30-day follow-up (30 days after discontinuation of GS-1423), post treatment follow-up (3 months)Population: The Immunogenicity Analysis Set included all participants in the Safety Analysis Set who have at least 1 nonmissing postdose ADA status reported.
Outcome measures
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
n=1 Participants
GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
n=1 Participants
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
n=3 Participants
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
n=3 Participants
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
n=3 Participants
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
n=7 Participants
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
n=3 Participants
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)
30-Day Follow-Up
|
100.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)
Baseline
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)
During the Treatment
|
100.0 percentage of participants
|
0 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)
Cycle 2 Day 1
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
66.7 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)
Cycle 3 Day 1
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)
Cycle 4 Day 1
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)
Cycle 4 Day 15
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)
Cycle 6 Day 1
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 1a Part A: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs)
Post Treatment Follow-Up (3 months)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
n=1 participants at risk
GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
n=1 participants at risk
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
n=3 participants at risk
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
n=3 participants at risk
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
n=3 participants at risk
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
n=7 participants at risk
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
n=3 participants at risk
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
General disorders
Disease progression
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Vascular disorders
Aortic embolus
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
Other adverse events
| Measure |
Phase 1a (Part A) Cohort 1: GS-1423 0.3 mg/kg
n=1 participants at risk
GS-1423 0.3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 2: GS-1423 1 mg/kg
n=1 participants at risk
GS-1423 1 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 3: GS-1423 3 mg/kg
n=3 participants at risk
GS-1423 3 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 4: GS-1423 10 mg/kg
n=3 participants at risk
GS-1423 10 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 5: GS-1423 20 mg/kg
n=3 participants at risk
GS-1423 20 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 6: GS-1423 30 mg/kg
n=7 participants at risk
GS-1423 30 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
Phase 1a (Part A) Cohort 7: GS-1423 45 mg/kg
n=3 participants at risk
GS-1423 45 mg/kg of body weight, solution for IV infusion, administered over approximately 60 minutes, on Day 1 of each 2-week cycle until the participant met study treatment discontinuation criteria or for up to 1 year.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Eye disorders
Exophthalmos
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
28.6%
2/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
28.6%
2/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
28.6%
2/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
General disorders
Chest discomfort
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
57.1%
4/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Investigations
Weight increased
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
28.6%
2/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
100.0%
3/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to eye
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
28.6%
2/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
28.6%
2/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
28.6%
2/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
14.3%
1/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: First dose date up to 30 days after permanent withdrawal of GS-1423 (maximum exposure: 26.3 weeks); All-Cause Mortality: Enrollment up to 22 months
Adverse Events and Serious Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER