Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP) (NCT NCT01054443)
NCT ID: NCT01054443
Last Updated: 2021-03-18
Results Overview
Responders were participants with one of the following: 1. achieved a platelet count of ≥ 50,000 cells/µL after 6 weeks of dosing; or 2. prematurely withdrawn due to a platelet count \> 400,000 cells/µL prior to Day 42. Participants were counted as non-responders if any of the following conditions held: * The above conditions were not satisfied; * They received rescue medications; * They satisfied the above conditions after receiving restricted medications during the treatment period; * They had achieved a platelet count of ≥ 50,000 cells/µL before Week 6 but not after Week 6; or * They withdrew for any reason other than a platelet count \> 400,000 cells/µL.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Week 6
Results posted on
2021-03-18
Participant Flow
Participants were randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups to receive lusutrombopag 0.5 mg, 0.75 mg, or 1.0 mg or placebo administered orally once daily for 42 days. Randomization was stratified according to Screening platelet count (\< 30,000 cells/μL or ≥ 30,000 cells/μL to \< 50,000 cells/μL).
Participant milestones
| Measure |
Placebo
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)
Baseline characteristics by cohort
| Measure |
Placebo
n=5 Participants
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=5 Participants
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 18.24 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 24.60 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 23.40 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 15.39 • n=4 Participants
|
54.7 years
STANDARD_DEVIATION 20.36 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Platelet Count at Screening
< 30,000 cells /μL
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Platelet Count at Screening
≥ 30,000 cells/μL to < 50,000 cells/μL
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: The full analysis set included all randomized participants who received at least 1 dose of study drug and had a platelet count at Baseline and at least 1 platelet count after randomized study drug was taken.
Responders were participants with one of the following: 1. achieved a platelet count of ≥ 50,000 cells/µL after 6 weeks of dosing; or 2. prematurely withdrawn due to a platelet count \> 400,000 cells/µL prior to Day 42. Participants were counted as non-responders if any of the following conditions held: * The above conditions were not satisfied; * They received rescue medications; * They satisfied the above conditions after receiving restricted medications during the treatment period; * They had achieved a platelet count of ≥ 50,000 cells/µL before Week 6 but not after Week 6; or * They withdrew for any reason other than a platelet count \> 400,000 cells/µL.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=5 Participants
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Percentage of Participants With a Response
|
0.0 percentage of participants
Could not be estimated when number of responses = 0
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
0.0 percentage of participants
Could not be estimated when number of responses = 0
|
0.0 percentage of participants
Could not be estimated when number of responses = 0
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Full analysis set participants who completed 6 weeks of treatment.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=4 Participants
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Change From Baseline in Platelet Count at Week 6
|
-3566.0 cells/µL
Standard Error 6400.05
|
21978.1 cells/µL
Standard Error 6095.54
|
8235.4 cells/µL
Standard Error 6465.37
|
-2809.4 cells/µL
Standard Error 6866.08
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Participants in the full analysis set with platelet counts ≥ 50,000 cells/μL at any time during the 6-week treatment period.
Duration of response was defined as the percentage of the cumulative time a platelet count was ≥ 50,000 cells/µL during the treatment period.
Outcome measures
| Measure |
Placebo
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=4 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=3 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=1 Participants
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Duration of Response
|
—
|
0.399 percentage of days
Interval 0.06 to 0.81
|
0.426 percentage of days
Interval 0.33 to 0.55
|
0.103 percentage of days
Interval 0.103 to 0.103
|
SECONDARY outcome
Timeframe: Week 6Population: Participants in the full analysis set who completed 6 weeks of treatment
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=4 Participants
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Platelet Count of ≥ 30,000 Cells/µL and Doubled the Baseline Platelet Count After 6 Weeks of Dosing
|
0.0 percentage of participants
|
60.0 percentage of participants
|
20.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: Participants in the full analysis set who completed 6 weeks of treatment
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=4 Participants
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Platelet Count of ≥ 50,000 Cells/µL and Doubled the Baseline Platelet Count After 6 Weeks of Dosing
|
0.0 percentage of participants
|
40.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set
Bleeding assessments were performed by the Investigator according to the World Health Organization (WHO) criteria bleeding scale: Grade 0: no bleeding; Grade 1: petechial bleeding; Grade 2: mild blood loss (clinically significant); Grade 3: gross blood loss, requires transfusion (severe); Grade 4: debilitating blood loss, retinal or cerebral associated with fatality. For each participant, the most severe WHO bleeding grade observed during the 6-week treatment period is reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=5 Participants
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period,
Grade 1
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period,
Grade 0
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period,
Grade 2
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period,
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period,
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Full analysis set
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=5 Participants
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Number of Participants Who Received Rescue Medication During the Treatment Period
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The safety population included all participants who received at least 1 dose of study drug
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product during the course of a clinical investigation, including any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product (IP), whether or not thought to be related to the IP. AEs reported after initial study drug administration were considered treatment-emergent. A serious adverse event is defined as any AE that resulted in death, was life-threatening, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect or an important medical event that, based upon medical judgment, may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. A treatment-related AE is any AE determined by the investigator to be possibly related, probably related, or definitely related to study drug.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=5 Participants
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any treatment-emergent adverse event
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related adverse events
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse events leading to withdrawal of study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 8, 22, and 36, after dosingPopulation: Participants who received at least 1 dose of study drug
Plasma concentrations of lusutrombopag were determined using a validated liquid chromatography mass spectrometry method. The lower limit of quantification (LOQ) for the plasma assay for lusutrombopag was 0.1 ng/mL.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Lusutrombopag Plasma Concentration
Day 8
|
16.5 ng/mL
Geometric Coefficient of Variation 35.40
|
21.7 ng/mL
Geometric Coefficient of Variation 52.77
|
33.3 ng/mL
Geometric Coefficient of Variation 32.74
|
—
|
|
Lusutrombopag Plasma Concentration
Day 22
|
19.1 ng/mL
Geometric Coefficient of Variation 32.10
|
19.6 ng/mL
Geometric Coefficient of Variation 32.20
|
30.7 ng/mL
Geometric Coefficient of Variation 42.97
|
—
|
|
Lusutrombopag Plasma Concentration
Day 36
|
24.1 ng/mL
Geometric Coefficient of Variation 14.22
|
21.1 ng/mL
Geometric Coefficient of Variation 36.33
|
30.4 ng/mL
Geometric Coefficient of Variation 40.28
|
—
|
SECONDARY outcome
Timeframe: Days 8, 22, and 36, after dosingPopulation: Participants who received at least 1 dose of study drug, with available data at each time point.
Plasma concentrations of the major metabolite S-888711 deshexyl were determined using a validated liquid chromatography mass spectrometry method. The lower limit of quantification (LOQ) for the plasma assay for S-888711 deshexyl was 0.1 ng/mL.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 Participants
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 Participants
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Plasma Concentration of Metabolite S-888711 Deshexyl
Day 8
|
0.1 ng/mL
Geometric Coefficient of Variation 68.10
|
0.3 ng/mL
Geometric Coefficient of Variation 176.69
|
0.2 ng/mL
Geometric Coefficient of Variation 50.41
|
—
|
|
Plasma Concentration of Metabolite S-888711 Deshexyl
Day 22
|
0.1 ng/mL
Geometric Coefficient of Variation 23.87
|
0.2 ng/mL
Geometric Coefficient of Variation 141.38
|
0.2 ng/mL
Geometric Coefficient of Variation 50.20
|
—
|
|
Plasma Concentration of Metabolite S-888711 Deshexyl
Day 36
|
0.1 ng/mL
Geometric Coefficient of Variation 28.15
|
0.2 ng/mL
Geometric Coefficient of Variation 154.49
|
0.2 ng/mL
Geometric Coefficient of Variation 101.93
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lusutrombopag 0.5 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Lusutrombopag 0.75 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Lusutrombopag 1.0 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=5 participants at risk
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 participants at risk
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 participants at risk
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=5 participants at risk
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
Other adverse events
| Measure |
Placebo
n=5 participants at risk
Participants received placebo tablets orally once a day for 42 days.
|
Lusutrombopag 0.5 mg
n=5 participants at risk
Participants received 0.5 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 0.75 mg
n=5 participants at risk
Participants received 0.75 mg lusutrombopag orally once a day for 42 days.
|
Lusutrombopag 1.0 mg
n=5 participants at risk
Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
General disorders
Cyst
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
General disorders
Fatigue
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
General disorders
Inflammation
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
General disorders
Oedema
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
General disorders
Vessel puncture site haemorrhage
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
General disorders
Muscle spasms
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • 6 weeks
|
60.0%
3/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Nervous system disorders
Clumsiness
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Investigations
Blood glucose increased
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Eye disorders
Conjunctival hyperaemia
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Eye disorders
Vision blurred
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
|
Social circumstances
Victim of sexual abuse
|
0.00%
0/5 • 6 weeks
|
20.0%
1/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
0.00%
0/5 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER