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Trial record 42 of 734 for:    warfarin

A Pharmacokinetics, Pharmacodynamics and Safety Study of Warfarin in Combination With Tamiflu (Oseltamivir)

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ClinicalTrials.gov Identifier: NCT02780622
Recruitment Status : Completed
First Posted : May 23, 2016
Results First Posted : September 12, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Drug Therapy, Combination
Interventions Drug: Oseltamivir
Drug: Warfarin
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title First Warfarin Then Warfarin and Oseltamivir First Warfarin and Oseltamivir Then Warfarin
Hide Arm/Group Description Participants received warfarin (on Days 1-5) in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received oseltamivir 75 milligram (mg) (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study. Participants received oseltamivir 75 mg (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received warfarin (on Days 1-5) in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
Period Title: Treatment Period 1
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Treatment Period 2
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description Participants were randomized to 1 of 2 treatment sequences: warfarin then oseltamivir 75 mg and warfarin; or oseltamivir 75 mg and warfarin then warfarin.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Analysis was performed on all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
62.4  (8.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
6
  30.0%
Male
14
  70.0%
1.Primary Outcome
Title Area Under the Plasma Effect-time Curve Over 96 Hours (AUEC[0-96 h]) for International Normalized Ratio (INR)
Hide Description INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. The net AUEC(0-96 h) was calculated using the linear trapezoidal rule; this was the area under the effect-time curve and above the baseline minus the area above the curve and below the baseline during the 5-day period. An increase in INR signifies enhancement of warfarin’s anticoagulant effect.
Time Frame Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Mean (Full Range)
Unit of Measure: hours*ratio
-2.16
(-27.6 to 78.0)
-9.06
(-93.6 to 18.0)
2.Primary Outcome
Title Change From Baseline in Maximum Observed Effect (Emax) of International Normalized Ratio (INR)
Hide Description INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. An increase in INR signifies enhancement of warfarin’s anticoagulant effect.
Time Frame Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Mean (Full Range)
Unit of Measure: ratio
0.3
(0.0 to 2.1)
0.1
(0.0 to 0.5)
3.Primary Outcome
Title Time to Reach Maximum Change From Baseline in International Normalized Ratio (INR) (Tmax)
Hide Description INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. An increase in INR signifies enhancement of warfarin's anticoagulant effect.
Time Frame Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Median (Full Range)
Unit of Measure: hours
24.00
(0.00 to 96.0)
0.00
(0.00 to 96.00)
4.Primary Outcome
Title Area Under the Plasma Effect-time Curve Over 96 Hours (AUEC[0-96 h]) for Factor VII Activity
Hide Description Factor VIIa is a protein that causes blood to clot, and low levels in the blood can cause excessive or prolonged bleeding after an injury or surgery. The net AUEC(0-96 h) was calculated using the linear trapezoidal rule; this was the area under the effect-time curve and above the baseline minus the area above the curve and below the baseline during the 5-day period. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect. kIU/L = 1000 * international units per liter.
Time Frame Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with available data.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 19 19
Mean (Full Range)
Unit of Measure: hours*kIU/L
0.568
(-9.48 to 7.56)
1.45
(-5.16 to 12.5)
5.Primary Outcome
Title Change From Baseline in Maximum Observed Effect (Emax) in Factor VII Activity
Hide Description Factor VIIa is a protein that causes blood to clot. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect. kIU/L = 1000 * international units per liter.
Time Frame Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with available data.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 19 19
Mean (Full Range)
Unit of Measure: kIU/L
-0.0505
(-0.21 to 0.00)
-0.0432
(-0.15 to 0.00)
6.Primary Outcome
Title Time to Reach Maximum Change From Baseline in Factor VII Activity (Tmax)
Hide Description Factor VIIa is a protein that causes blood to clot. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect.
Time Frame Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with available data.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 19 19
Median (Full Range)
Unit of Measure: hours
96.00
(0.00 to 96.00)
72.00
(0.00 to 96.00)
7.Primary Outcome
Title Change From Baseline in Plasma Concentration of Vitamin K1
Hide Description Vitamin K1 is required by proteins involved in blood clotting. Food interaction with warfarin can lead to decreases in Vitamin K1 in plasma. An increase in vitamin K1 signifies enhancement of warfarin's anticoagulant effect.
Time Frame Pre-dose on Day 1 and 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Mean (Full Range)
Unit of Measure: nanogram per liter (ng/L)
305
(-371 to 1060)
271
(-1100 to 1310)
8.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) for Oseltamivir and Oseltamivir Carboxylate
Hide Description Oseltamivir carboxylate is an active metabolite of oseltamivir.
Time Frame Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: hours
Oseltamivir (Single Dose: Day 1)
0.50
(0.50 to 3.00)
Oseltamivir Carboxylate (Single Dose: Day 1)
4.00
(2.00 to 6.00)
Oseltamivir (Steady State: Day 5)
0.75
(0.50 to 3.00)
Oseltamivir Carboxylate (Steady State: Day 5)
4.00
(3.00 to 6.00)
9.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) for R- and S- Warfarin
Hide Description [Not Specified]
Time Frame Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Median (Full Range)
Unit of Measure: hours
Total (S)-warfarin
2.00
(1.00 to 8.13)
4.00
(0.00 to 23.92)
Free (S)-warfarin
14.5
(8.74 to 53.8)
3.01
(1.00 to 8.00)
Total (R)-warfarin
3.00
(1.00 to 11.83)
4.00
(1.00 to 23.92)
Free (R)-warfarin
4.00
(1.00 to 11.83)
3.00
(1.00 to 11.83)
10.Secondary Outcome
Title Terminal Half-life (t½) for Oseltamivir and Oseltamivir Carboxylate
Hide Description Oseltamivir carboxylate is an active metabolite of oseltamivir.
Time Frame Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: hours
Oseltamivir (Single Dose: Day 1) 1.77  (0.686)
Oseltamivir Carboxylate (Single Dose: Day 1) 6.17  (2.07)
Oseltamivir (Steady State: Day 5) 4.00  (3.08)
Oseltamivir Carboxylate (Steady State: Day 5) 8.19  (1.90)
11.Secondary Outcome
Title Terminal Half-life (t½) for R- and S- Warfarin
Hide Description [Not Specified]
Time Frame Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: hours
Total (S)-warfarin (n = 13, 11) 45.4  (23.0) 45.6  (11.7)
Total (R)-warfarin (n = 12, 12) 56.1  (26.1) 53.6  (12.2)
12.Secondary Outcome
Title Oral Plasma Clearance (CL/F) for Oseltamivir
Hide Description [Not Specified]
Time Frame Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: liters per hour (L/h)
Oseltamivir (Single Dose: Day 1) 558  (134)
Oseltamivir (Steady State: Day 5) 463  (104)
13.Secondary Outcome
Title Oral Plasma Clearance (CL/F) for R- and S- Warfarin
Hide Description [Not Specified]
Time Frame Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: liters per hour (L/h)
Total (S)-warfarin 0.198  (0.0895) 0.208  (0.0959)
Free (S)-warfarin 38.5  (17) 38.2  (15.1)
Total (R)-warfarin 0.139  (0.0361) 0.145  (0.0374)
Free (R)-warfarin 21.7  (5.74) 22  (5.54)
14.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) for Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Oseltamivir (Single Dose: Day 1) 88.9  (50.0)
Oseltamivir Carboxylate (Single Dose: Day 1) 367  (107)
Oseltamivir (Steady State: Day 5) 91.2  (47.2)
Oseltamivir Carboxylate (Steady State: Day 5) 571  (160)
15.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) for R- and S- Warfarin
Hide Description R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the Cmax values (nanograms per milliliter) by the individual average dose (milligrams).
Time Frame Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Nanogram/milliliter/milligram (ng/mL/mg)
Total (S)-warfarin 394  (259) 330  (197)
Free (S)-warfarin 1.87  (1.30) 1.68  (1.13)
Total (R)-warfarin 436  (243) 375  (96.3)
Free (R)-warfarin 2.70  (1.45) 2.37  (0.604)
16.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) for Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 and 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Oseltamivir (Steady state: Day 5) 176  (38.5)
Oseltamivir Carboxylate (Steady State: Day 5) 7180  (2550)
17.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) for R- and S- Warfarin
Hide Description R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the AUC values (hours multiplied by nanograms, per milliliter) by the individual average dose (milligrams).
Time Frame Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: h*ng/mL/mg
Total (S)-warfarin 6770  (4500) 6460  (4310)
Free (S)-warfarin 35.2  (26.1) 33.9  (24.1)
Total (R)-warfarin 7790  (2480) 7360  (1960)
Free (R)-warfarin 49.4  (13.4) 48.3  (11.9)
18.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 12 Hours (AUC0-12h) for Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Oseltamivir (Single Dose: Day 1) 141  (38.3)
Oseltamivir Carboxylate (Single Dose: Day 1) 2990  (793)
Oseltamivir (Steady State: Day 5) 169  (36.3)
Oseltamivir Carboxylate (Steady State: Day 5) 5110  (1630)
19.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 12 Hours (AUC0-12h) for R- and S- Warfarin
Hide Description R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the AUC values (hours multiplied by nanograms, per milliliter) by the individual average dose (milligrams).
Time Frame Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: h*ng/mL/mg
Total (S)-warfarin 3610  (2200) 3380  (2100)
Free (S)-warfarin 18.6  (13.0) 17.8  (12.3)
Total (R)-warfarin 4140  (1320) 3870  (1020)
Free (R)-warfarin 25.9  (7.84) 24.8  (6.36)
20.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Up to Day 26
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description:
Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percentage of participants
25.0 25.0
Time Frame Five days for each treatment period (Up to Day 26)
Adverse Event Reporting Description All enrolled participants.
 
Arm/Group Title Warfarin Warfarin and Oseltamivir
Hide Arm/Group Description Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2. Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
All-Cause Mortality
Warfarin Warfarin and Oseltamivir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Warfarin Warfarin and Oseltamivir
Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)   0/20 (0.00%) 
Cardiac disorders     
Angina pectoris  1  1/20 (5.00%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Warfarin Warfarin and Oseltamivir
Affected / at Risk (%) Affected / at Risk (%)
Total   4/20 (20.00%)   5/20 (25.00%) 
Gastrointestinal disorders     
Diarrhoea  1  0/20 (0.00%)  1/20 (5.00%) 
General disorders     
Venipuncture site swelling  1  0/20 (0.00%)  1/20 (5.00%) 
Infections and infestations     
Fungal skin infection  1  1/20 (5.00%)  0/20 (0.00%) 
Oral herpes  1  1/20 (5.00%)  0/20 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/20 (0.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/20 (5.00%)  0/20 (0.00%) 
Joint effusion  1  1/20 (5.00%)  0/20 (0.00%) 
Nervous system disorders     
Headache  1  0/20 (0.00%)  2/20 (10.00%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain  1  0/20 (0.00%)  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02780622     History of Changes
Other Study ID Numbers: WP21272
2007-005037-11 ( EudraCT Number )
First Submitted: May 20, 2016
First Posted: May 23, 2016
Results First Submitted: July 25, 2016
Results First Posted: September 12, 2016
Last Update Posted: October 26, 2016