Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN) (NCT NCT03285711)
NCT ID: NCT03285711
Last Updated: 2020-05-18
Results Overview
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Baseline; Week 16
Results posted on
2020-05-18
Participant Flow
Participants were enrolled at study sites in United States. The first participant was screened on 06 October 2017. The last study visit occurred on 03 February 2020.
22 participants were screened.
Participant milestones
| Measure |
Lanraplenib 30 mg
Participants received lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment for additional 16 weeks.
After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.
|
Filgotinib 200 mg
Participants received filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment for additional 16 weeks.
After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.
|
Lanraplenib 30 mg to Filgotinib 200 mg
At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received filgotinib 200 mg + lanraplenib placebo for additional 16 weeks.
At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.
|
Filgotinib 200 mg to Lanraplenib 30 mg
At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received lanraplenib 30 mg + filgotinib placebo for additional 16 weeks.
At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.
|
|---|---|---|---|---|
|
Blinded Phase (Up to Week 16)
STARTED
|
4
|
5
|
0
|
0
|
|
Blinded Phase (Up to Week 16)
COMPLETED
|
1
|
4
|
0
|
0
|
|
Blinded Phase (Up to Week 16)
NOT COMPLETED
|
3
|
1
|
0
|
0
|
|
Blinded Phase (Week 16 to 32)
STARTED
|
0
|
3
|
1
|
1
|
|
Blinded Phase (Week 16 to 32)
COMPLETED
|
0
|
3
|
0
|
1
|
|
Blinded Phase (Week 16 to 32)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Extended Blinded Phase (Week 32 to 52)
STARTED
|
0
|
3
|
0
|
1
|
|
Extended Blinded Phase (Week 32 to 52)
COMPLETED
|
0
|
2
|
0
|
1
|
|
Extended Blinded Phase (Week 32 to 52)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lanraplenib 30 mg
Participants received lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment for additional 16 weeks.
After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.
|
Filgotinib 200 mg
Participants received filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment for additional 16 weeks.
After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.
|
Lanraplenib 30 mg to Filgotinib 200 mg
At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received filgotinib 200 mg + lanraplenib placebo for additional 16 weeks.
At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.
|
Filgotinib 200 mg to Lanraplenib 30 mg
At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received lanraplenib 30 mg + filgotinib placebo for additional 16 weeks.
At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.
|
|---|---|---|---|---|
|
Blinded Phase (Up to Week 16)
Adverse Event
|
2
|
1
|
0
|
0
|
|
Blinded Phase (Up to Week 16)
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Blinded Phase (Week 16 to 32)
Lack of Efficacy
|
0
|
0
|
1
|
0
|
|
Extended Blinded Phase (Week 32 to 52)
Lack of Efficacy
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
Baseline characteristics by cohort
| Measure |
Lanraplenib 30 mg
n=4 Participants
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
Filgotinib 200 mg
n=5 Participants
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
35 years
STANDARD_DEVIATION 16.9 • n=7 Participants
|
35 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 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
|
1 Participants
n=7 Participants
|
1 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
|
24-Hour Urine Protein
|
6.0 g/day
STANDARD_DEVIATION 4.65 • n=5 Participants
|
3.3 g/day
STANDARD_DEVIATION 2.47 • n=7 Participants
|
4.5 g/day
STANDARD_DEVIATION 3.62 • n=5 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
116.1 mL/min/1.73m^2
STANDARD_DEVIATION 55.41 • n=5 Participants
|
102.6 mL/min/1.73m^2
STANDARD_DEVIATION 30.61 • n=7 Participants
|
108.6 mL/min/1.73m^2
STANDARD_DEVIATION 40.87 • n=5 Participants
|
|
Urine Protein Creatinine Ratio (UPCR)
|
5.1 mg/mg
STANDARD_DEVIATION 4.38 • n=5 Participants
|
1.9 mg/mg
STANDARD_DEVIATION 1.04 • n=7 Participants
|
3.3 mg/mg
STANDARD_DEVIATION 3.23 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 16Population: Participants in the Full Analysis Set (included all randomized participants who took at least 1 dose of study drug) with available data were analyzed.
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
Outcome measures
| Measure |
Lanraplenib 30 mg
n=1 Participants
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
Filgotinib 200 mg
n=4 Participants
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
|---|---|---|
|
Percent Change in Urine Protein From Baseline (Day 1) to Week 16
|
-2.8 percent change
|
-51.2 percent change
Standard Deviation 25.67
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: Participants in the Full Analysis Set with available data were analyzed.
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
Outcome measures
| Measure |
Lanraplenib 30 mg
n=1 Participants
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
Filgotinib 200 mg
n=4 Participants
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
|---|---|---|
|
Change From Baseline (Day 1) in Urine Protein at Week 16
|
-0.177 g/day
|
-2.151 g/day
Standard Deviation 2.2591
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Lanraplenib 30 mg
n=1 Participants
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
Filgotinib 200 mg
n=4 Participants
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
|---|---|---|
|
Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16
|
-59.4 mL/min/1.73 m^2
|
-2.0 mL/min/1.73 m^2
Standard Deviation 11.35
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: Participants in the Full Analysis Set with available data were analyzed.
UPCR was assessed by urine protein excretion during a 24-hour urine collection.
Outcome measures
| Measure |
Lanraplenib 30 mg
n=1 Participants
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
Filgotinib 200 mg
n=4 Participants
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
|---|---|---|
|
Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16
|
-4.407 mg/mg
|
-0.808 mg/mg
Standard Deviation 0.7539
|
SECONDARY outcome
Timeframe: Week 16Population: Participants in the Full Analysis Set with available data were analyzed.
Partial Remission was defined as urine protein excretion below \< 3 g/day and urine protein excretion decrease by ≥ 50% among participants with baseline (Day 1) nephrotic range proteinuria \[urine protein excretion ≥ 3 g/day\]; or urine protein excretion decrease by ≥ 50% among participants with subnephrotic range proteinuria \[urine protein excretion \< 3 g/day\]).
Outcome measures
| Measure |
Lanraplenib 30 mg
n=1 Participants
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
Filgotinib 200 mg
n=4 Participants
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
|---|---|---|
|
Percentage of Participants With Partial Remission at Week 16
|
0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Participants in the Full Analysis Set with available data were analyzed.
Complete Remission was defined as urine protein excretion below 0.5 g/day, with no hematuria.
Outcome measures
| Measure |
Lanraplenib 30 mg
n=1 Participants
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
Filgotinib 200 mg
n=4 Participants
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
|---|---|---|
|
Percentage of Participants With Complete Remission at Week 16
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Up to Week 16: Lanraplenib 30 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Up to Week 16: Filgotinib 200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
After Week 16: Lanraplenib 30 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
After Week 16: Filgotinib 200 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Up to Week 16: Lanraplenib 30 mg
n=4 participants at risk
Participants received lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
Up to Week 16: Filgotinib 200 mg
n=5 participants at risk
Participants received filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
After Week 16: Lanraplenib 30 mg
At Week 16, participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment (lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily) for additional 16 weeks.
After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.
|
After Week 16: Filgotinib 200 mg
n=3 participants at risk
At Week 16, participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment (filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily) for additional 16 weeks.
After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.
|
After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg
n=1 participants at risk
At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received filgotinib 200 mg + lanraplenib placebo for additional 16 weeks.
At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.
|
After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg
n=1 participants at risk
At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received lanraplenib 30 mg + filgotinib placebo for additional 16 weeks.
At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Up to Week 16: Lanraplenib 30 mg
n=4 participants at risk
Participants received lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
Up to Week 16: Filgotinib 200 mg
n=5 participants at risk
Participants received filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
|
After Week 16: Lanraplenib 30 mg
At Week 16, participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment (lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily) for additional 16 weeks.
After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.
|
After Week 16: Filgotinib 200 mg
n=3 participants at risk
At Week 16, participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment (filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily) for additional 16 weeks.
After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.
|
After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg
n=1 participants at risk
At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received filgotinib 200 mg + lanraplenib placebo for additional 16 weeks.
At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.
|
After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg
n=1 participants at risk
At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received lanraplenib 30 mg + filgotinib placebo for additional 16 weeks.
At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
100.0%
1/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
40.0%
2/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
100.0%
1/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Eye disorders
Amaurosis fugax
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
100.0%
1/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
50.0%
2/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
100.0%
1/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
100.0%
1/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
100.0%
1/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
—
0/0 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
100.0%
1/1 • First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took 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