Trial Outcomes & Findings for Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus (NCT NCT03472326)
NCT ID: NCT03472326
Last Updated: 2021-01-05
Results Overview
The criteria for analyzing percentage of participants with plasma HIV-1 RNA \> 0.5 log10 decrease from baseline in randomized cohort was at least 50% of the participants should achieve HIV-1 RNA \> 0.5 log10 decrease from baseline in the Part 1 sentinel cohort 2.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Day 15
Results posted on
2021-01-05
Participant Flow
Participants were enrolled at study sites in Uganda and Zimbawe. The first participant was screened on 03 April 2018. The last study visit occurred on 09 December 2019.
88 participants were screened. The study was conducted in 2 parts. The Part 1 consisted of 3 cohorts- 2 Sentinel Cohorts and 1 Randomized Cohort and Part 2 consisted of 2 Sentinel Cohorts only. The Randomized Cohort in Part 1 was not initiated. The study was terminated because a majority of Sentinel Cohort 2 (Part 1) participants did not meet primary endpoint of human immunodeficiency virus ribonucleic acid (HIV-1 RNA) \> 0.5 log10 decrease from baseline in through up to 14 days of therapy.
Participant milestones
| Measure |
Part 1 Sentinel Cohort 1: GS-9131 60 mg
Participants received GS-9131 60 mg tablets orally once daily in addition to their current failing antiretroviral (ARV) regimen for a period of 10 days.
|
Part 1 Sentinel Cohort 2: GS-9131 180 mg
Participants received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days.
|
Part 2 Sentinel Cohort 1: GS-9131 + BIC + DRV + RTV
Participants who completed dosing in Sentinel Cohort 1 and showed a reduction in plasma HIV RNA \> 0.5 log10 from their pre-GS-9131 baseline value at Day 11 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 60 mg tablets + bictegravir (BIC) 30 mg tablets + darunavir (DRV) 800 mg tablets + ritonavir (RTV) 100 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants had the option to participate in an open label extension and receive GS-9131 60 mg tablets + BIC 75 mg tablets + tenofovir alafenamide (TAF) 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first.
|
Part 2 Sentinel Cohort 2: GS-9131 + BIC + TAF
Participants who completed dosing in Sentinel Cohort 2 and showed a reduction in plasma HIV RNA \> 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants had the option to participate in an open label extension and receive GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first.
|
|---|---|---|---|---|
|
Part 1: GS-9131 Functional Monotherapy
STARTED
|
11
|
10
|
0
|
0
|
|
Part 1: GS-9131 Functional Monotherapy
COMPLETED
|
11
|
10
|
0
|
0
|
|
Part 1: GS-9131 Functional Monotherapy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2: Combination Therapy
STARTED
|
0
|
0
|
1
|
3
|
|
Part 2: Combination Therapy
COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2: Combination Therapy
NOT COMPLETED
|
0
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
Part 1 Sentinel Cohort 1: GS-9131 60 mg
Participants received GS-9131 60 mg tablets orally once daily in addition to their current failing antiretroviral (ARV) regimen for a period of 10 days.
|
Part 1 Sentinel Cohort 2: GS-9131 180 mg
Participants received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days.
|
Part 2 Sentinel Cohort 1: GS-9131 + BIC + DRV + RTV
Participants who completed dosing in Sentinel Cohort 1 and showed a reduction in plasma HIV RNA \> 0.5 log10 from their pre-GS-9131 baseline value at Day 11 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 60 mg tablets + bictegravir (BIC) 30 mg tablets + darunavir (DRV) 800 mg tablets + ritonavir (RTV) 100 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants had the option to participate in an open label extension and receive GS-9131 60 mg tablets + BIC 75 mg tablets + tenofovir alafenamide (TAF) 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first.
|
Part 2 Sentinel Cohort 2: GS-9131 + BIC + TAF
Participants who completed dosing in Sentinel Cohort 2 and showed a reduction in plasma HIV RNA \> 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants had the option to participate in an open label extension and receive GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first.
|
|---|---|---|---|---|
|
Part 2: Combination Therapy
Study Terminated by Sponsor
|
0
|
0
|
1
|
2
|
|
Part 2: Combination Therapy
Pregnancy
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus
Baseline characteristics by cohort
| Measure |
Sentinel Cohort 1: GS-9131 60 mg
n=11 Participants
Participants in Sentinel Cohort 1 received GS-9131 60 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 10 days in Part 1.
|
Sentinel Cohort 2: GS-9131 180 mg
n=10 Participants
Participants in Sentinel Cohort 2 received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days in Part 1.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
37 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
38 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Uganda
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Zimbabwe
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
HIV-1 RNA
|
4.77 log10 copies/mL
STANDARD_DEVIATION 0.703 • n=5 Participants
|
4.46 log10 copies/mL
STANDARD_DEVIATION 0.584 • n=7 Participants
|
4.62 log10 copies/mL
STANDARD_DEVIATION 0.652 • n=5 Participants
|
|
HIV-1 RNA Category
< 50 copies/mL
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
HIV-1 RNA Category
≥ 50 copies/mL
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
CD4 Cell Count
|
172 cells/µL
STANDARD_DEVIATION 164.1 • n=5 Participants
|
289 cells/µL
STANDARD_DEVIATION 140.4 • n=7 Participants
|
228 cells/µL
STANDARD_DEVIATION 161.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Data was not analyzed as ≥ 50% participants did not achieve HIV-1 RNA \> 0.5 log10 decrease from baseline in Part 1 sentinel cohort 2.
The criteria for analyzing percentage of participants with plasma HIV-1 RNA \> 0.5 log10 decrease from baseline in randomized cohort was at least 50% of the participants should achieve HIV-1 RNA \> 0.5 log10 decrease from baseline in the Part 1 sentinel cohort 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 11Population: The Safety Analysis Set included all participants who took at least 1 dose of study medication.
Outcome measures
| Measure |
Part 1: Randomized Cohort
n=11 Participants
Participants were randomized in 1:1:1:1 so as to receive GS-9131 tablets orally once daily in 3 active dose levels up to a maximum of 180 mg or Placebo to match GS-9131 tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days in Part 1.
|
Part 2: GS-9131 + BIC + TAF
Participants who completed dosing in Sentinel Cohort 2 and showed a reduction in plasma HIV RNA \> 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first.
|
|---|---|---|
|
Part 1 Sentinel Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Day 11
|
-0.13 log10 copies/mL
Standard Deviation 0.268
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Part 1: Randomized Cohort
n=8 Participants
Participants were randomized in 1:1:1:1 so as to receive GS-9131 tablets orally once daily in 3 active dose levels up to a maximum of 180 mg or Placebo to match GS-9131 tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days in Part 1.
|
Part 2: GS-9131 + BIC + TAF
Participants who completed dosing in Sentinel Cohort 2 and showed a reduction in plasma HIV RNA \> 0.5 log10 from their pre-GS-9131 baseline value at Day 15 and discontinued their current failing regimen received an optimized regimen consisting of GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for a period of 24 weeks. After Week 24, participants will be given the option to participate in an open label extension and receive GS-9131 180 mg tablets + BIC 75 mg tablets + TAF 25 mg tablets, orally once daily for an additional 24 weeks or until Gilead Sciences elects to discontinue the study drug in that country, whichever occurred first.
|
|---|---|---|
|
Part 1 Sentinel Cohort 2: Change From Baseline in Plasma log10 HIV-1 RNA at Day 15
|
-0.29 log10 copies/mL
Standard Deviation 0.207
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: Data was not reported as the Randomized Cohort in Part 1 was not initiated as the study was terminated early because a majority of Sentinel Cohort 2 participants did not meet primary endpoint of HIV-1 RNA \> 0.5 log10 decrease from baseline in through up to 14 days of therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Population: Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose up to Week 24Population: Due to early study termination, data were not collected as none of the participants qualified for resistance testing after Week 8.
Treatment emergent virological failure was defined as an event with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of the study drug. Virologic failure was defined as virologic rebound or as suboptimal virologic response in relation to pre-GS-9131 baseline plasma HIV-1 RNA levels. Virological rebound was defined as if participant at any visit after achieving HIV-1 RNA \< 50 copies/mL, a rebound in HIV-1 RNA ≥ 50 copies/mL, or a \>1 log10 increase in HIV-1 RNA from the nadir which was subsequently confirmed at the following scheduled or unscheduled visit. Suboptimal virologic response was defined as plasma HIV-1 RNA ≥ 200 copies/mL and reduction in HIV-1 RNA ≤ 1 log10 from pre-GS-9131 baseline at the Week 8 visit with confirmation at the next scheduled or unscheduled visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose up to Week 24Population: Due to early study termination, data were not collected as none of the participants qualified for resistance testing after Week 8.
Treatment emergent virological failure was defined as an event with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of the study drug. Virologic failure was defined as virologic rebound or as suboptimal virologic response in relation to pre-GS-9131 baseline plasma HIV-1 RNA levels. Virological rebound was defined as if participant at any visit after achieving HIV-1 RNA \< 50 copies/mL, a rebound in HIV-1 RNA ≥ 50 copies/mL, or a \>1 log10 increase in HIV-1 RNA from the nadir which was subsequently confirmed at the following scheduled or unscheduled visit. Suboptimal virologic response was defined as plasma HIV-1 RNA ≥ 200 copies/mL and reduction in HIV-1 RNA ≤ 1 log10 from pre-GS-9131 baseline at the Week 8 visit with confirmation at the next scheduled or unscheduled visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose up to Week 24Population: Due to early study termination, data were not collected as none of the participants qualified for resistance testing after Week 8.
Treatment emergent virological failure was defined as an event with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of the study drug. Virologic failure was defined as virologic rebound or as suboptimal virologic response in relation to pre-GS-9131 baseline plasma HIV-1 RNA levels. Virological rebound was defined as if participant at any visit after achieving HIV-1 RNA \< 50 copies/mL, a rebound in HIV-1 RNA ≥ 50 copies/mL, or a \>1 log10 increase in HIV-1 RNA from the nadir which was subsequently confirmed at the following scheduled or unscheduled visit. Suboptimal virologic response was defined as plasma HIV-1 RNA ≥ 200 copies/mL and reduction in HIV-1 RNA ≤ 1 log10 from pre-GS-9131 baseline at the Week 8 visit with confirmation at the next scheduled or unscheduled visit.
Outcome measures
Outcome data not reported
Adverse Events
Part 1 Setinel Cohort 1: GS-9131 60 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 Sentinel Cohort 2: GS-9131 180 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Setinel Cohort 1: GS-9131 60 mg
n=11 participants at risk
Participants in Sentinel Cohort 1 received GS-9131 60 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 10 days in Part 1.
|
Part 1 Sentinel Cohort 2: GS-9131 180 mg
n=10 participants at risk
Participants in Sentinel Cohort 2 received GS-9131 180 mg tablets orally once daily in addition to their current failing ARV regimen for a period of 14 days in Part 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
1/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
0.00%
0/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
20.0%
2/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
20.0%
2/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
20.0%
2/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
General disorders
Malaise
|
9.1%
1/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
General disorders
Oedema peripheral
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
General disorders
Pain
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Infections and infestations
Cellulitis
|
9.1%
1/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
0.00%
0/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Infections and infestations
Rhinitis
|
9.1%
1/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
30.0%
3/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Investigations
Amylase increased
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
30.0%
3/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
30.0%
3/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
20.0%
2/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
40.0%
4/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Psychiatric disorders
Pica
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
20.0%
2/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/11 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
10.0%
1/10 • From first dose date up to 30 days after last study drug for Part 1 (Maximum: 44 days)
The Safety Analysis Set included all participants (in Sentinal Cohorts 1 and 2 in part 1) who took at least 1 dose of study medication. Due to the early discontinuation of the study, safety analyses were performed for Sentinel Cohorts in Part 1 only. In Part 2, Data were collected for only 1 participant, and due to participant confidentiality data is not being reported.
|
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