Trial Outcomes & Findings for A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment (NCT NCT00999336)
NCT ID: NCT00999336
Last Updated: 2023-08-22
Results Overview
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in nanogram multiplied by hour per milliliter (ng\*h/mL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Predose up to 168 hours postdose
Results posted on
2023-08-22
Participant Flow
A total of 32 eligible participants were enrolled into 1 of 4 groups (8 participants per group) at screening according to the estimated glomerular filtration rate (eGFR).
Criteria based on age, gender, and weight were planned in order to match participants in the renal function groups and to ensure that renal function groups were comparable to each other.
Participant milestones
| Measure |
Normal Renal Function
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
Baseline characteristics by cohort
| Measure |
Normal Renal Function
n=8 Participants
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment according to the eGFR.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
66 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
69 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
61 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
64 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
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
Not Hispanic or Latino
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Predose up to 168 hours postdosePopulation: All participants with varying degrees of renal function who received the study intervention.
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in nanogram multiplied by hour per milliliter (ng\*h/mL).
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Area Under The Plasma Concentration-Time Curve From Time Zero To 24 Hours (AUC0-24) Postdose Of Oral Doses Of Betrixaban On Day 8
|
437 ng*h/mL
Standard Deviation 237
|
807 ng*h/mL
Standard Deviation 254
|
1033 ng*h/mL
Standard Deviation 549
|
995 ng*h/mL
Standard Deviation 445
|
PRIMARY outcome
Timeframe: Predose, up to 168 hours postdosePopulation: All participants with varying degrees of renal function who received the study intervention.
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in nanogram per milliliter (ng/mL).
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Administration Of Oral Doses Of Betrixaban On Day 8
|
44.0 ng/mL
Standard Deviation 24.4
|
84.3 ng/mL
Standard Deviation 37.0
|
108 ng/mL
Standard Deviation 59.1
|
104 ng/mL
Standard Deviation 58.0
|
PRIMARY outcome
Timeframe: Predose, up to 168 hours postdosePopulation: All participants with varying degrees of renal function who received the study intervention.
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Harmonic mean and Jackknife standard deviation was used to report this outcome and results were reported in hour.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Plasma Terminal Elimination Half-Life (T½) Following Administration Of Oral Doses Of Betrixaban On Day 8
|
54.4 hour
Standard Deviation 9.20
|
56.0 hour
Standard Deviation 5.09
|
60.7 hour
Standard Deviation 8.17
|
55.6 hour
Standard Deviation 5.19
|
PRIMARY outcome
Timeframe: Predose, up to 168 hours postdosePopulation: All participants with varying degrees of renal function who received the study intervention.
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in milliliter per minute (mL/min).
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Total Plasma Clearance (CL/F) Following Administration Of Oral Doses Of Betrixaban On Day 8
|
4042 mL/min
Standard Deviation 2376
|
1815 mL/min
Standard Deviation 623
|
1887 mL/min
Standard Deviation 1468
|
1715 mL/min
Standard Deviation 1052
|
PRIMARY outcome
Timeframe: Predose, up to 168 hours postdosePopulation: All participants with varying degrees of renal function who received the study intervention.
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in liter.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Volume Of Distribution During The Terminal Phase (Vz/F) Following Administration Of Oral Doses Of Betrixaban On Day 8
|
20128 liter
Standard Deviation 13391
|
8795 liter
Standard Deviation 2780
|
9518 liter
Standard Deviation 6183
|
9562 liter
Standard Deviation 6132
|
PRIMARY outcome
Timeframe: Predose, up to 24 hours postdosePopulation: All participants with varying degrees of renal function who received the study intervention.
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in percentage.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Percentage Of Dose Excreted In Urine From 0-24 (fe0-24) Postdose Of Oral Doses Of Betrixaban On Day 8
|
5.07 percentage of excreted dose
Standard Deviation 2.32
|
5.40 percentage of excreted dose
Standard Deviation 2.24
|
5.04 percentage of excreted dose
Standard Deviation 2.38
|
2.72 percentage of excreted dose
Standard Deviation 1.02
|
PRIMARY outcome
Timeframe: 4 hours Postdose at Day 8Population: All participants with varying degrees of renal function who received the study intervention.
Blood samples were collected for measurement of plasma protein binding for betrixaban for all participants. Results of protein binding assays were summarized by sample time and eGFR group. Results were reported in percent (%).
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Percentage Of Betrixaban Bound To Plasma Proteins On Day 8
|
58.6 percentage of bound betrixaban
Standard Deviation 2.76
|
61.3 percentage of bound betrixaban
Standard Deviation 1.86
|
59.4 percentage of bound betrixaban
Standard Deviation 3.05
|
59.9 percentage of bound betrixaban
Standard Deviation 3.62
|
PRIMARY outcome
Timeframe: Day 1: predose; Day 8: 2, 3, 4, 8, 24, and 48 hours postdosePopulation: All participants with varying degrees of renal function who received the study intervention.
Blood samples were collected at the protocol-specified time points. Plasma samples were assayed for measurement of thrombin generation for all participants.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 1 Predose
|
12494 relative fluorescence units (RFU)
Standard Error 2256.4
|
14168 relative fluorescence units (RFU)
Standard Error 3387.2
|
11833 relative fluorescence units (RFU)
Standard Error 3283.1
|
10021 relative fluorescence units (RFU)
Standard Error 6034.7
|
|
Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 2 h
|
6359 relative fluorescence units (RFU)
Standard Error 2819.6
|
4484 relative fluorescence units (RFU)
Standard Error 1411.4
|
4873 relative fluorescence units (RFU)
Standard Error 1466.4
|
4773 relative fluorescence units (RFU)
Standard Error 2059.1
|
|
Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 3 h
|
6611 relative fluorescence units (RFU)
Standard Error 1544.6
|
5356 relative fluorescence units (RFU)
Standard Error 1632.2
|
5098 relative fluorescence units (RFU)
Standard Error 1850.4
|
5547 relative fluorescence units (RFU)
Standard Error 2994.4
|
|
Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 4 h
|
6899 relative fluorescence units (RFU)
Standard Error 1528.6
|
5103 relative fluorescence units (RFU)
Standard Error 1406.7
|
6216 relative fluorescence units (RFU)
Standard Error 3092.5
|
6154 relative fluorescence units (RFU)
Standard Error 2818.6
|
|
Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 8 h
|
9716 relative fluorescence units (RFU)
Standard Error 1386.6
|
8789 relative fluorescence units (RFU)
Standard Error 2923.8
|
7907 relative fluorescence units (RFU)
Standard Error 2851.0
|
7482 relative fluorescence units (RFU)
Standard Error 1959.3
|
|
Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 24 h
|
8616 relative fluorescence units (RFU)
Standard Error 2336.2
|
5870 relative fluorescence units (RFU)
Standard Error 2205.7
|
7386 relative fluorescence units (RFU)
Standard Error 1275.8
|
8013 relative fluorescence units (RFU)
Standard Error 2710.4
|
|
Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 48 h
|
12233 relative fluorescence units (RFU)
Standard Error 3872.4
|
8350 relative fluorescence units (RFU)
Standard Error 2863.9
|
8119 relative fluorescence units (RFU)
Standard Error 1742.7
|
8485 relative fluorescence units (RFU)
Standard Error 2858.0
|
PRIMARY outcome
Timeframe: Day 8: 2, 3, 4, 8, 24, and 48 hours postdosePopulation: All participants with varying degrees of renal function who received the study intervention.
Blood samples were collected at the protocol-specified time points. Plasma samples were assayed for measurement of anti-fXa activity at baseline and steady state for all participants. Results were reported in international units per milliliter (IU/mL).
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
Participants with normal renal function according to the eGFR.
|
Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 8 h
|
0.10 IU/mL
Standard Deviation 0.066
|
0.18 IU/mL
Standard Deviation 0.070
|
0.32 IU/mL
Standard Deviation 0.245
|
0.30 IU/mL
Standard Deviation 0.276
|
|
Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 24 h
|
0.06 IU/mL
Standard Deviation 0.054
|
0.13 IU/mL
Standard Deviation 0.056
|
0.18 IU/mL
Standard Deviation 0.138
|
0.18 IU/mL
Standard Deviation 0.123
|
|
Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 48 h
|
NA IU/mL
Standard Deviation NA
Here, 'NA' signifies that the data was below the limit of quantification (BLQ) (0.1 IU/mL).
|
0.08 IU/mL
Standard Deviation 0.032
|
0.13 IU/mL
Standard Deviation 0.082
|
0.12 IU/mL
Standard Deviation 0.092
|
|
Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 2 h
|
0.18 IU/mL
Standard Deviation 0.113
|
0.36 IU/mL
Standard Deviation 0.293
|
0.48 IU/mL
Standard Deviation 0.352
|
0.44 IU/mL
Standard Deviation 0.237
|
|
Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 3 h
|
0.27 IU/mL
Standard Deviation 0.302
|
0.40 IU/mL
Standard Deviation 0.163
|
0.60 IU/mL
Standard Deviation 0.393
|
0.77 IU/mL
Standard Deviation 0.453
|
|
Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8
Day 8 4 h
|
0.22 IU/mL
Standard Deviation 0.302
|
0.33 IU/mL
Standard Deviation 0.116
|
0.58 IU/mL
Standard Deviation 0.381
|
0.58 IU/mL
Standard Deviation 0.310
|
Adverse Events
Normal Renal Function
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Mild Renal Impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Moderate Renal Impairment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Severe Renal Impairment
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normal Renal Function
n=8 participants at risk
Participants with normal renal function according to the estimated eGFR.
|
Mild Renal Impairment
n=8 participants at risk
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 participants at risk
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 participants at risk
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
Other adverse events
| Measure |
Normal Renal Function
n=8 participants at risk
Participants with normal renal function according to the estimated eGFR.
|
Mild Renal Impairment
n=8 participants at risk
Participants with mild renal impairment according to the eGFR.
|
Moderate Renal Impairment
n=8 participants at risk
Participants with moderate renal impairment according to the eGFR.
|
Severe Renal Impairment
n=8 participants at risk
Participants with severe renal impairment according to the eGFR.
|
|---|---|---|---|---|
|
Vascular disorders
Gingival Bleeding
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
25.0%
2/8 • Number of events 2 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Vascular disorders
Epistaxis
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Eye disorders
Vision Blurred
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
General disorders
Fatigue
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Day 1 through up to Day 12
|
25.0%
2/8 • Number of events 2 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
12.5%
1/8 • Number of events 1 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
25.0%
2/8 • Number of events 2 • Day 1 through up to Day 12
|
0.00%
0/8 • Day 1 through up to Day 12
|
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place