Trial Outcomes & Findings for Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma (NCT NCT02468557)
NCT ID: NCT02468557
Last Updated: 2021-04-02
Results Overview
TEAEs were defined as adverse events (AEs) with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the study drug. It also included the AEs that led to premature discontinuation of study drug.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
First dose date up to last dose date (Maximum: 8 weeks) plus 30 days
Results posted on
2021-04-02
Participant Flow
Participants were enrolled at study sites in the United States. The first participant was screened on 30 July 2015. The last study visit occurred on 27 April 2016.
35 participants were screened. The study was terminated. No participants were enrolled in the Idelalisib (IDL) + nab-paclitaxel or IDL + mFOLFOX \[5- fluorouracil (FU), leucovorin and oxaliplatin\] groups.
Participant milestones
| Measure |
Idelalisib 150 mg
Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Idelalisib 150 mg
Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Study Terminated by Sponsor, Regulatory Agency or Institutional Review Board/ Ethics Committee
|
10
|
|
Overall Study
All Enrolled but Never Dosed
|
4
|
Baseline Characteristics
Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Idelalisib 150 mg
n=12 Participants
Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
|
|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First dose date up to last dose date (Maximum: 8 weeks) plus 30 daysPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
TEAEs were defined as adverse events (AEs) with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the study drug. It also included the AEs that led to premature discontinuation of study drug.
Outcome measures
| Measure |
Idelalisib 150 mg
n=12 Participants
Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
|
Idelalisib + mFOLFOX6
Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.
|
Idelalisib + mFOLFOX6
Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.
|
|---|---|---|---|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
|
100.0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: First dose date up to last dose date (Maximum: 8 weeks) plus 30 daysPopulation: Participants in the safety analysis set were analysed.
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post baseline time point, up to and including the date of last dose of study drug plus 30 days. If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Severity grade is defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening). The percentage of participants for any post-baseline abnormal laboratory value in the Grade 1-4 category is reported. The term 'hypo' indicates less than the normal count of a parameter and 'hyper' indicates more than the normal count of a parameter.
Outcome measures
| Measure |
Idelalisib 150 mg
n=12 Participants
Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
|
Idelalisib + mFOLFOX6
Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.
|
Idelalisib + mFOLFOX6
Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.
|
|---|---|---|---|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Lymphocytes (Hyper), Hematology
|
8.3 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Hemoglobin (Hypo), Hematology
|
25.0 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Lymphocytes (Hypo), Hematology
|
25.0 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Platelets, Hematology
|
8.3 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Alanine Aminotransferase, Chemistry
|
58.3 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Albumin, Chemistry
|
16.7 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Alkaline Phosphatase, Chemistry
|
33.3 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Aspartate Aminotransferase, Chemistry
|
66.7 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Bilirubin, Chemistry
|
16.7 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Creatinine Clearance, Chemistry
|
16.7 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Gamma Glutamyl Transferase, Chemistry
|
50.0 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Glucose (Hyper), Chemistry
|
16.7 percentage of participants
|
—
|
—
|
|
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Sodium (Hypo), Chemistry
|
25.0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Due to the early termination of the study, there were no participants enrolled in the Idelalisib Combination arms.
Dose limiting toxicities were defined as toxicities experienced during the first 28 days of treatment (Cycle 1) that were judged to be clinically significant and at least possibly related to study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to the early termination of the study no pharmacodynamic testing was performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 hours (h) postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdosePopulation: The pharmacokinetic (PK) Analysis Set included all participants in the Full Analysis Set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest. Due to the early termination of the study, concentration data is reported because there was an insufficient number of participants sampled for PK analysis to generate PK parameters.
Outcome measures
| Measure |
Idelalisib 150 mg
n=12 Participants
Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
|
Idelalisib + mFOLFOX6
Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.
|
Idelalisib + mFOLFOX6
Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.
|
|---|---|---|---|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (Predose)
|
NA ng/mL
The plasma concentration of IDL was below the limit of quantitation.
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (0.5 h)
|
1110 ng/mL
Interval 13.9 to 3220.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (1 h)
|
1880 ng/mL
Interval 39.1 to 4060.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (1.5 h)
|
1690 ng/mL
Interval 318.0 to 2260.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (2 h)
|
1290 ng/mL
Interval 173.0 to 4460.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (3 h)
|
795 ng/mL
Interval 631.0 to 2870.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (4 h)
|
1540 ng/mL
Interval 519.0 to 1990.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (8 h)
|
251 ng/mL
Interval 134.0 to 753.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 8 (Predose)
|
264 ng/mL
Interval 208.0 to 501.5
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 8 (1.5 h)
|
2050 ng/mL
Interval 1335.0 to 2620.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 15 (Predose)
|
275 ng/mL
Interval 241.0 to 1120.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 15 (1.5 h)
|
1605 ng/mL
Interval 1170.0 to 2130.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 2; Day 1 (Predose)
|
178.05 ng/mL
Interval 39.05 to 281.0
|
—
|
—
|
|
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 2; Day 1 (1.5 h)
|
2180 ng/mL
Interval 1825.0 to 3095.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 h postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdosePopulation: Participants in the PK Analysis Set with available data were analysed. Due to the early termination of the study, concentration data is reported because there was an insufficient number of participants sampled for PK analysis to generate PK parameters.
Outcome measures
| Measure |
Idelalisib 150 mg
n=12 Participants
Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
|
Idelalisib + mFOLFOX6
Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.
|
Idelalisib + mFOLFOX6
Participants were to be administered IDL tablets orally twice daily plus mFOLFOX6 administered intravenously on Days 1 and 15 of each 28 day cycle.
|
|---|---|---|---|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (8 h)
|
632 ng/mL
Interval 619.0 to 5340.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 8 (Predose)
|
2175 ng/mL
Interval 1385.0 to 5790.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (Predose)
|
NA ng/mL
The plasma concentration of GS-563117 was below the limit of quantitation.
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (0.5 h)
|
173 ng/mL
Interval to 220.0
The plasma concentration of GS-563117 was below the limit of quantitation.
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (1 h)
|
1220 ng/mL
Interval 16.7 to 1460.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (1.5 h)
|
1070 ng/mL
Interval 141.0 to 1930.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (2 h)
|
1700 ng/mL
Interval 106.0 to 4430.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (3 h)
|
1580 ng/mL
Interval 190.0 to 5980.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 1 (4 h)
|
1370 ng/mL
Interval 849.0 to 5960.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 8 (1.5 h)
|
2775 ng/mL
Interval 1765.0 to 5725.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 15 (Predose)
|
2130 ng/mL
Interval 1020.0 to 6800.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 1; Day 15 (1.5 h)
|
2890 ng/mL
Interval 2010.0 to 4815.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 2; Day 1 (Predose)
|
1046.5 ng/mL
Interval 490.34 to 1360.0
|
—
|
—
|
|
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily
Cycle 2; Day 1 (1.5 h)
|
1405 ng/mL
Interval 1325.0 to 2305.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to early study termination, the prespecified efficacy analyses were not conducted.
Overall response rate (ORR) was defined as the percentage of participants who achieved a Complete Response (CR) or Partial Response (PR) as assessed by response evaluation criteria in sold tumors (RECIST) v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to early study termination, the prespecified efficacy analyses were not conducted.
Overall survival is defined as the interval from first dose date of study drug to death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Due to early study termination, the prespecified efficacy analyses were not conducted.
Progression free survival is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression or death from any cause.
Outcome measures
Outcome data not reported
Adverse Events
Idelalisib 150 mg
Serious events: 3 serious events
Other events: 12 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Idelalisib 150 mg
n=12 participants at risk
Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Idelalisib 150 mg
n=12 participants at risk
Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal spasm
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
16.7%
2/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
41.7%
5/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Xerosis
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
3/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
4/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Aphasia
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Chromaturia
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
2/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
2/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
2/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Adverse Events: First dose date up to last dose date (Maximum: 8 weeks) plus 30 days All-cause mortality: First dose date up to study termination (approximately 39 weeks)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
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