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Trial record 68 of 118 for:    oseltamivir

A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance

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ClinicalTrials.gov Identifier: NCT01556633
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Volunteer
Intervention Drug: Tamiflu (oseltamivir)
Enrollment 16
Recruitment Details A total of 27 participants were screened and 16 participants were enrolled in the study. The study was conducted from 09 March 2012 to 23 June 2012 at two study centers in New Zealand.
Pre-assignment Details  
Arm/Group Title Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Hide Arm/Group Description Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule. Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
Period Title: Overall Study
Started 10 6
Completed 10 6
Not Completed 0 0
Arm/Group Title Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg) Total
Hide Arm/Group Description Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule. Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule. Total of all reporting groups
Overall Number of Baseline Participants 10 6 16
Hide Baseline Analysis Population Description
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 6 participants 16 participants
52.8  (16.62) 66.3  (9.95) 57.9  (15.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 16 participants
Female
5
  50.0%
1
  16.7%
6
  37.5%
Male
5
  50.0%
5
  83.3%
10
  62.5%
1.Primary Outcome
Title Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Hide Description

CLDAPD is the total dialysate clearance for automated peritoneal dialysis, attributable to both continuous cycler-assisted peritoneal dialysis (CCPD) and continuous ambulatory peritoneal dialysis (CAPD), which was calculated with the recovery method over the dense blood sampling collection interval from 0 to 48 hours post-dose.

CLDAPD = the amount excreted into dialysate from 0 to 48 hours (Aed[0-48])/ plasma area under the concentration-time curve from time zero through 48 hours (AUC[0-48])

CLDCCPD = mean of CLDCCPD from the 2 CCPD sessions, calculated as CLDCCPD = (Aed[0-8]/AUC[0-8] + Aed[24-32]/AUC[24-32]) / 2

CLDCAPD = mean of CLDCAPD from the 3 CAPD sessions, calculated as CLDCAPD = (Aed[8-16]/AUC[8-16] + Aed[16-24]/AUC[16-24] + Aed[32-48]/AUC[32-48]) / 3

Time Frame CCPD: pre-dose (0)-2.67, 2.67-5.33, 5.33-8; CAPD: 8-16, 16-24; CCPD: 24-26.67, 26.67-29.33, 29.33-32; CAPD: 32-40, 40-48 hrs post-dose for urine; CCPD and CAPD:0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48 hrs post-dose for blood
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: Only 9 participants were included for this analysis as they did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or if data was unavailable or incomplete which influence the PK analysis were excluded from the PK analysis population.
Arm/Group Title Dialysis (Oseltamivir 75 mg)
Hide Arm/Group Description:
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Litre (L)/hour (h)
Oseltamivir, CLDAPD
NA [1] 
(NA%)
Oseltamivir, CLDCAPD
NA [2] 
(NA%)
Oseltamivir, CLDCCPD
0.183
(23.8%)
Oseltamivir Carboxylate CLDAPD
0.230
(13.1%)
Oseltamivir Carboxylate, CLDCAPD
0.187
(11.8%)
Oseltamivir Carboxylate, CLDCCPD
0.326
(18.5%)
[1]
CLDAPD is a derived from CLDCCPD and CLDCAPD. Since CLDCAPD could not be calculated as no oseltamivir concentration was found in the dialysate; therefore, CLDAPD could not be derived.
[2]
CLDCAPD could not be calculated as no oseltamivir concentration was found in the dialysate.
2.Primary Outcome
Title AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Hide Description AUC120 is defined as the area under the plasma concentration-time curve from time zero through 120 hours post-dose, AUC168 is defined as the area under the plasma concentration-time curve from time zero through 168 hours post-dose, and AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
Time Frame Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n".
Arm/Group Title Dialysis (Oseltamivir 75 mg)
Hide Arm/Group Description:
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram (ng)*h/ milliliter (mL)
AUC120 oseltamivir (n = 6)
175
(33.3%)
AUC168 oseltamivir (n = 6)
175
(33.3%)
AUCinf oseltamivir (n = 6)
175
(33.3%)
AUC120 oseltamivir carboxylate (n = 9)
83400
(88.9%)
AUC168 oseltamivir carboxylate (n = 9)
89200
(96.0%)
AUCinf oseltamivir carboxylate (n = 9)
93800
(102.5%)
3.Primary Outcome
Title AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose
Hide Description AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
Time Frame Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n".
Arm/Group Title Reduced Creatinine Clearance (Oseltamivir 30 mg)
Hide Arm/Group Description:
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
AUCinf, oseltamivir (n = 3)
64.7
(46.2%)
AUCinf, oseltamivir carboxylate (n = 6)
8630
(56.3%)
4.Primary Outcome
Title Cmax of Oseltamivir and Oseltamivir Carboxylate
Hide Description The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
Time Frame Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n".
Arm/Group Title Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Hide Arm/Group Description:
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
Overall Number of Participants Analyzed 9 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Oseltamivir (n = 9,5)
67.1
(79.4%)
22.1
(38.2%)
Oseltamivir carboxylate (n = 9,6)
1710
(31.0%)
361
(27.4%)
5.Primary Outcome
Title C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose
Hide Description

C120h is defined as the plasma concentration at 120 hours post-dose. C168h is defined as the plasma concentration at 168 hours post-dose. Clast is defined as the plasma concentration corresponding to the time of the last measureable (positive) plasma concentration.

Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.

Time Frame Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis.
Arm/Group Title Dialysis (Oseltamivir 75 mg)
Hide Arm/Group Description:
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
C120h, oseltamivir NA [1]   (NA)
C168h,oseltamivir NA [1]   (NA)
Clast, oseltamivir 1.30  (0.271)
C120h, oseltamivir carboxylate 301.0  (264.0)
C168h,oseltamivir carboxylate 138.0  (135.0)
Clast, oseltamivir carboxylate 140.0  (132.0)
[1]
For all participants the oseltamivir concentration was below lower limit of quantification and therefore a mean could not be calculated.
6.Primary Outcome
Title Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate
Hide Description

The Time of observed maximum plasma concentration (Tmax) is defined as actual sampling time to reach maximum observed analyte concentration.

The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.

Time Frame Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n".
Arm/Group Title Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Hide Arm/Group Description:
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
Overall Number of Participants Analyzed 9 6
Median (Full Range)
Unit of Measure: h
Tmax, Oseltamivir (n = 9, 5)
2.50
(0.50 to 4.00)
1.33
(0.50 to 4.00)
T1/2, Oseltamivir (n = 6,3)
1.92
(1.01 to 2.41)
2.25
(1.12 to 3.39)
Tmax, Oseltamivir carboxylate (n = 9, 6)
20.00
(6.67 to 28.00)
7.34
(6.67 to 12.07)
T1/2, Oseltamivir Carboxylate (n = 9,6)
35.3
(10.0 to 47.3)
10.7
(8.87 to 21.0)
7.Primary Outcome
Title Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate
Hide Description CLR is calculated as the cumulative amount of drug excreted into urine from 0 to time t hours (Ae0-tlast) / area under the concentration-time curve from time zero through the last quantifiable concentration time (AUC0-t).
Time Frame Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose for blood; pre-dose and 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hrs post-dose for urine.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by "n".
Arm/Group Title Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Hide Arm/Group Description:
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
Overall Number of Participants Analyzed 9 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
CLR, oseltamivir (n = 4, 5)
0.572
(441.3%)
3.30
(70.6%)
CLR, oseltamivir carboxylate (n = 4, 6)
0.655
(217.4%)
2.28
(81.3%)
8.Secondary Outcome
Title Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs)
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the intervention. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Time Frame Approximately 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
Arm/Group Title Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Hide Arm/Group Description:
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
Overall Number of Participants Analyzed 10 6
Measure Type: Number
Unit of Measure: participants
Any AEs 9 2
Any SAEs 1 0
9.Secondary Outcome
Title Number of Participants With Marked Abnormality in Laboratory Measurements
Hide Description

Laboratory analysis included: hematology (hemoglobin, hematocrit, reticulocyte, red blood cell, platelet and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin), prothrombin and activated partial thromboplastin time, biochemistry (sodium, potassium, bicarbonate, phosphate, chloride, calcium, urea, serum creatinine, bilirubin, cholesterol, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase [ALT], gamma-glutamyl transferase, protein, albumin, amylase, creatinine, lipase), random glucose, and urinalysis.

Laboratory test result values falling outside of the marked abnormality range that also represent a defined change from baseline were considered as marked laboratory abnormalities. A marked reference range for sodium is 130-150 millimole (mmol)/L, chloride is 95-115 mmol/L, phosphate is 0.75-1.60 mmol/L, calcium is 2-2.90 mmol/L, glucose is 2.8-11.10 mmol/L, bicarbonate is 18-28 mmol/L, and ALT is 0-110 Unit/L.

Time Frame Approximately 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
Arm/Group Title Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Hide Arm/Group Description:
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
Overall Number of Participants Analyzed 10 6
Measure Type: Number
Unit of Measure: participants
Sodium chloride 1 0
Chloride 3 0
Phosphate 3 0
Calcium 1 0
Glucose (random) 1 0
Bicarbonate 1 0
ALT 1 0
10.Secondary Outcome
Title Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit
Hide Description ECG parameter included QT interval, QTcB interval and QTcF interval (all intervals are measured in millisecond [msec]). Marked abnormality in ECG is predefined for QT, QTcB, and QTcF interval as <=30, >30-60, and >60 msec increase from baseline.
Time Frame From Baseline (Day -1) to Follow-up visit (Days 15 to 22)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
Arm/Group Title Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Hide Arm/Group Description:
Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
Overall Number of Participants Analyzed 10 6
Measure Type: Number
Unit of Measure: participants
QT, <= 30 8 6
QT, > 30 - 60 2 0
QTcB, <= 30 10 6
QTcF, <= 30 9 6
QTcF, > 30 - 60 1 0
11.Secondary Outcome
Title Number of Participants With Abnormal Shifts in Vital Signs
Hide Description

Vital signs included pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and body temperature.

Vital sign with abnormal shifts from normal at baseline to high or low at post-baseline time points were recorded. Blood pressure was recorded in millimeter of mercury (mmHg), and temperature in degrees Celsius. Low blood pressure defined as <=70 mmHg (SBP) and <=40 mmHg (DBP); high blood pressure defined as >=140 mmHg (SBP) and >=90 mmHg (DBP); low temperature defined as <=36.5 degrees Celsius and high temperature defined as >=37.5 degrees Celsius.

Time Frame Days 1 (post-dose), 2, 3, 4, 5, 6, 7, 8; and Follow-up visit (Days 15 to 22)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
Arm/Group Title Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Hide Arm/Group Description:
Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
Overall Number of Participants Analyzed 10 6
Measure Type: Number
Unit of Measure: participants
SBP , Day 1 – postdose, High 1 0
SBP, Day 2, High 2 1
SBP, Day 3, High 2 1
SBP, Day 4, High 2 1
SBP, Day 5, High 2 1
SBP, Day 7, High 1 1
SBP, Day 8, High 1 0
SBP, Follow Up, High 2 0
DBP, Day 2, High 0 1
DBP, Day 3, High 2 0
DBP, Day 7, High 0 1
DBP, Day 8, High 0 1
DBP, Follow Up, High 3 0
Temperature, Day 4, Low 2 0
Temperature, Day 6, Low 1 0
Temperature, Day 7, Low 1 0
Temperature, Day 8, Low 1 0
Temperature, Follow Up, Low 2 0
Time Frame Approximately 7 weeks
Adverse Event Reporting Description Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.
 
Arm/Group Title Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Hide Arm/Group Description Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule. Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
All-Cause Mortality
Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   0/6 (0.00%) 
Infections and infestations     
Respiratory tract infection  1  1/10 (10.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dialysis (Oseltamivir 75 mg) Reduced Creatinine Clearance (Oseltamivir 30 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/10 (90.00%)   2/6 (33.33%) 
Eye disorders     
Conjunctivitis allergic  1  1/10 (10.00%)  0/6 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/10 (10.00%)  0/6 (0.00%) 
Abdominal pain upper  1  1/10 (10.00%)  0/6 (0.00%) 
Diarrhea  1  1/10 (10.00%)  1/6 (16.67%) 
Gastroesophageal reflux disease  1  1/10 (10.00%)  0/6 (0.00%) 
Infrequent bowel movements  1  1/10 (10.00%)  0/6 (0.00%) 
Nausea  1  1/10 (10.00%)  1/6 (16.67%) 
Vomiting  1  1/10 (10.00%)  0/6 (0.00%) 
General disorders     
Catheter site hematoma  1  1/10 (10.00%)  0/6 (0.00%) 
Edema peripheral  1  1/10 (10.00%)  0/6 (0.00%) 
Pyrexia  1  1/10 (10.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  2/10 (20.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycemia  1  1/10 (10.00%)  0/6 (0.00%) 
Hypokalemia  1  1/10 (10.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/10 (10.00%)  0/6 (0.00%) 
Pain in jaw  1  1/10 (10.00%)  0/6 (0.00%) 
Nervous system disorders     
Dizziness  1  1/10 (10.00%)  0/6 (0.00%) 
Dizziness postural  1  1/10 (10.00%)  0/6 (0.00%) 
Headache  1  1/10 (10.00%)  1/6 (16.67%) 
Lethargy  1  1/10 (10.00%)  0/6 (0.00%) 
Parasthesia  1  1/10 (10.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/10 (10.00%)  0/6 (0.00%) 
Nasal congestion  1  2/10 (20.00%)  0/6 (0.00%) 
Upper airway obstruction  1  1/10 (10.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  1/10 (10.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01556633     History of Changes
Other Study ID Numbers: NV25655
First Submitted: March 15, 2012
First Posted: March 16, 2012
Results First Submitted: November 30, 2015
Results First Posted: July 7, 2016
Last Update Posted: July 7, 2016