Trial Outcomes & Findings for Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects (NCT NCT02034591)
NCT ID: NCT02034591
Last Updated: 2016-06-23
Results Overview
Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention
Results posted on
2016-06-23
Participant Flow
37 participants were enrolled; 21 were randomized and treated. Reasons for non-randomization include 11 no longer met study criteria, 1 withdrew consent and 4 for other, not specified reasons. 20 participants completed the study; 1 withdrew consent on day 4 of treatment.
Participant milestones
| Measure |
Treatment A, Then Treatment B, Then Treatment C
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
Treatment A, Then Treatment C, Then Treatment B
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
Treatment B, Then Treatment A, Then Treatment C
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
Treatment B, Then Treatment C, Then Treatment A
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
Treatment C, Then Treatment A, Then Treatment B
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
Treatment C, Then Treatment B, Then Treatment A
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
4
|
3
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
4
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment A, Then Treatment B, Then Treatment C
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
Treatment A, Then Treatment C, Then Treatment B
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
Treatment B, Then Treatment A, Then Treatment C
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
Treatment B, Then Treatment C, Then Treatment A
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
Treatment C, Then Treatment A, Then Treatment B
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
Treatment C, Then Treatment B, Then Treatment A
Each participant was given three interventions, one per period, with a 4 day washout in between periods
Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Treatment Groups
n=21 Participants
All Randomized Participants
|
|---|---|
|
Age, Continuous
|
36.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each interventionPopulation: All randomized participants with available pharmacokinetic (PK) data
Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)
Outcome measures
| Measure |
Treatment A
n=20 Participants
Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
|
Treatment B
n=20 Participants
Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
|
Treatment C
Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|
|
Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban
|
179.116 ng/mL
Interval 164.855 to 194.611
|
122.145 ng/mL
Interval 112.011 to 133.196
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each interventionPopulation: All randomized participants with available PK data
AUC(INF) is measured in nanogram hours per milliliter (ng\*h/mL)
Outcome measures
| Measure |
Treatment A
n=20 Participants
Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
|
Treatment B
n=20 Participants
Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
|
Treatment C
Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|
|
Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban
|
1397.666 ng*h/mL
Interval 1330.658 to 1468.049
|
1136.380 ng*h/mL
Interval 1065.716 to 1211.729
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each interventionPopulation: All randomized participants with available PK data
AUC(0-T) is measured in nanogram hours per milliliter (ng\*h/mL)
Outcome measures
| Measure |
Treatment A
n=20 Participants
Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
|
Treatment B
n=20 Participants
Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
|
Treatment C
Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|
|
Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban
|
1372.836 ng*h/mL
Interval 1306.24 to 1442.828
|
1112.493 ng*h/mL
Interval 1041.751 to 1188.038
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each interventionPopulation: All randomized participants with available PK data
Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)
Outcome measures
| Measure |
Treatment A
n=20 Participants
Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
|
Treatment B
n=21 Participants
Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
|
Treatment C
Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|
|
Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban
|
179.116 ng/mL
Interval 164.855 to 194.611
|
158.371 ng/mL
Interval 145.849 to 171.968
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each interventionPopulation: All randomized participants with available PK data
AUC(INF) is measured in nanogram hours per milliliter (ng\*h/mL)
Outcome measures
| Measure |
Treatment A
n=20 Participants
Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
|
Treatment B
n=21 Participants
Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
|
Treatment C
Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|
|
Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban
|
1397.666 ng*h/mL
Interval 1330.658 to 1468.049
|
1327.248 ng*h/mL
Interval 1246.871 to 1412.806
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each interventionPopulation: All randomized participants with available PK data
AUC(0-T) is measured in nanogram hours per milliliter (ng\*h/mL)
Outcome measures
| Measure |
Treatment A
n=20 Participants
Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
|
Treatment B
n=21 Participants
Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
|
Treatment C
Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|
|
Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban
|
1372.836 ng*h/mL
Interval 1306.24 to 1442.828
|
1300.728 ng*h/mL
Interval 1220.374 to 1386.374
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 30 days after last dose of study drugPopulation: All randomized participants
AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
Outcome measures
| Measure |
Treatment A
n=20 Participants
Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
|
Treatment B
n=20 Participants
Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
|
Treatment C
n=21 Participants
Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs
SAE
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs
Treatment-Related AE
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs
Deaths
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs
Treatment-Related Deaths
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs
Discontinuation of Study Drug Due to AEs
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to 30 days after last dose of study drugPopulation: All randomized participants
Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes \>1.2\* upper limits of normal (ULN) , Basophils \>3%, Eosinophils \>1.5\*ULN, Blood Urine \>=2, Red Blood Cell (RBC) Urine \>=2, White Blood Cell (WBC) Urine \>=2
Outcome measures
| Measure |
Treatment A
n=20 Participants
Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
|
Treatment B
n=20 Participants
Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
|
Treatment C
n=21 Participants
Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities
Leukocytes
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Basophils
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Eosinophils
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Blood, Urine
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
RBC, Urine
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
WBC, Urine
|
0 participants
|
2 participants
|
1 participants
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment C
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A
n=20 participants at risk
Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
|
Treatment B
n=20 participants at risk
Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
|
Treatment C
n=21 participants at risk
Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/20 • Day 1 to 30 days after last dose of study drug
|
4.8%
1/21 • Day 1 to 30 days after last dose of study drug
|
Other adverse events
| Measure |
Treatment A
n=20 participants at risk
Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
|
Treatment B
n=20 participants at risk
Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
|
Treatment C
n=21 participants at risk
Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
|
|---|---|---|---|
|
Vascular disorders
Haematoma
|
0.00%
0/20 • Day 1 to 30 days after last dose of study drug
|
5.0%
1/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/21 • Day 1 to 30 days after last dose of study drug
|
|
Renal and urinary disorders
Pyuria
|
5.0%
1/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/21 • Day 1 to 30 days after last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/21 • Day 1 to 30 days after last dose of study drug
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Day 1 to 30 days after last dose of study drug
|
5.0%
1/20 • Day 1 to 30 days after last dose of study drug
|
4.8%
1/21 • Day 1 to 30 days after last dose of study drug
|
|
Eye disorders
Vision blurred
|
5.0%
1/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/21 • Day 1 to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.0%
1/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/21 • Day 1 to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/21 • Day 1 to 30 days after last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Day 1 to 30 days after last dose of study drug
|
5.0%
1/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/21 • Day 1 to 30 days after last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/20 • Day 1 to 30 days after last dose of study drug
|
5.0%
1/20 • Day 1 to 30 days after last dose of study drug
|
0.00%
0/21 • Day 1 to 30 days after last dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60