Anemia
Conditions
Brief summary
This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.
Interventions
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients \>=18 years of age; * chronic renal anemia; * on hemodialysis therapy for at least 3 months; * receiving iv epoetin alfa during the 2 weeks prior to the run-in period.
Exclusion criteria
* women who are pregnant, breastfeeding or using unreliable birth control methods; * use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen | From Baseline (Day -28 to Day 1) to EOIT (Week 19) | Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen | From Baseline (Day -28 to Day 1) to EOIT (Week 19) | Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value. |
| Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths | Up to Week 126 | An Adverse Events (AEs) is 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. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. ). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only. |
| Number of Participants With Marked Laboratory Abnormalities | Up to Week 126 | Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10\^9/L), Platelets (100 - 550 10\^9/L), Alanine aminotransferase (ALAT) \[0 110 units per litre (U/L)\], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (0 - 80 U/L), Albumin \>= 30 g/L, Phosphate \[0.75 - 1.60 millimoles per liter (mmol/L)\], Potassium (2.9 - 5.8 mmol/L), Glucose (2.80 - 11.10 mmol/L). |
| Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | From Baseline (Day -28 to Day 1) to Week 126 | Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). |
| Mean Change in Pulse Rate | Up to Week 126 | Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported. |
Countries
United States
Participant flow
Recruitment details
A total of 91 participants were enrolled in this study conducted from 19 March 2002 to 08 June 2005 at 14 Sites in United States.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 15 |
| Cohort 2 (RO0503821 [0.25/150 1x/2 Week]) Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 15 |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 15 |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 15 |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 16 |
| Cohort 6 (RO0503821 [0.6/150 1x/2 Week]) Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 15 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Core Period | Early Withdrawals | 4 | 2 | 1 | 1 | 1 | 1 | 0 | 0 |
| Extension Year 1 | Early Withdrawals | 0 | 0 | 0 | 0 | 0 | 0 | 11 | 11 |
| Extension Year 2 | Early Withdrawals | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 |
Baseline characteristics
| Characteristic | Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Cohort 2 (RO0503821 [0.25/150 1x/2 Week]) | Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Cohort 6 (RO0503821 [0.6/150 1x/2 Week]) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 50.2 years STANDARD_DEVIATION 9.9 | 58.6 years STANDARD_DEVIATION 12.64 | 53.8 years STANDARD_DEVIATION 12.72 | 62.8 years STANDARD_DEVIATION 15.76 | 60.1 years STANDARD_DEVIATION 11.89 | 62.5 years STANDARD_DEVIATION 10.77 | 58.00 years STANDARD_DEVIATION 12.91 |
| Gender Female | 2 Participants | 8 Participants | 6 Participants | 6 Participants | 6 Participants | 3 Participants | 31 Participants |
| Gender Male | 13 Participants | 7 Participants | 9 Participants | 9 Participants | 10 Participants | 12 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 46 | 30 / 45 |
| serious Total, serious adverse events | 20 / 46 | 20 / 45 |
Outcome results
Primary
Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Population: The Intent-to-Treat (ITT) population was defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen | -0.29 g/dL |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen | -0.92 g/dL |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen | -0.04 g/dL |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen | -0.46 g/dL |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen | 0.86 g/dL |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen | -0.07 g/dL |
Comparison: All cohorts with dosing frequency 1 X / Week90% CI: [0.32, 0.42]
Comparison: All cohorts with dosing frequency 1 X /2 Week90% CI: [0.53, 0.76]
Secondary
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1).
Time frame: From Baseline (Day -28 to Day 1) to Week 126
Population: The safety population was considered for analysis which included all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP- before dialysis | -2 mm HG | Standard Deviation 12.2 |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP - After dialysis | 4 mm HG | Standard Deviation 16.7 |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - before dialysis | -1 mm HG | Standard Deviation 26.4 |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - After dialysis | 6 mm HG | Standard Deviation 30.1 |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - before dialysis | 5 mm HG | Standard Deviation 25.5 |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP - After dialysis | 0 mm HG | Standard Deviation 19 |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP- before dialysis | -1 mm HG | Standard Deviation 14.7 |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - After dialysis | 3 mm HG | Standard Deviation 26.5 |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - After dialysis | -3 mm HG | Standard Deviation 30.4 |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - before dialysis | -15 mm HG | Standard Deviation 21.6 |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP - After dialysis | -0 mm HG | Standard Deviation 14.5 |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP- before dialysis | -10 mm HG | Standard Deviation 12.4 |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP- before dialysis | -8 mm HG | Standard Deviation 14.3 |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - After dialysis | -13 mm HG | Standard Deviation 26.7 |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP - After dialysis | -8 mm HG | Standard Deviation 18 |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - before dialysis | -15 mm HG | Standard Deviation 23.8 |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - before dialysis | -11 mm HG | Standard Deviation 21.7 |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - After dialysis | -6 mm HG | Standard Deviation 27.1 |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP - After dialysis | -6 mm HG | Standard Deviation 18.1 |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP- before dialysis | -6 mm HG | Standard Deviation 13.1 |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP - After dialysis | -0 mm HG | Standard Deviation 14.5 |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - before dialysis | -15 mm HG | Standard Deviation 21.6 |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | SBP - After dialysis | -3 mm HG | Standard Deviation 30.4 |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | DBP- before dialysis | -10 mm HG | Standard Deviation 12.4 |
Secondary
Mean Change in Pulse Rate
Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.
Time frame: Up to Week 126
Population: The safety population was considered for analysis which included all participants who received at least one dose of study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Mean Change in Pulse Rate | -1 BpM | Standard Deviation 10.1 |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Mean Change in Pulse Rate | 1 BpM | Standard Deviation 14.8 |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Mean Change in Pulse Rate | 2 BpM | Standard Deviation 10.5 |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Mean Change in Pulse Rate | 3 BpM | Standard Deviation 14.1 |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Mean Change in Pulse Rate | -1 BpM | Standard Deviation 10.2 |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Mean Change in Pulse Rate | 3 BpM | Standard Deviation 12.6 |
Secondary
Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Population: The Intent-to-Treat (ITT) population was defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen | -1.50 g/dL |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen | -3.01 g/dL |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen | -0.32 g/dL |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen | -1.62 g/dL |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen | 2.73 g/dL |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen | -0.07 g/dL |
Secondary
Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
An Adverse Events (AEs) is 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. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. ). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
Time frame: Up to Week 126
Population: The safety population was considered for analysis which included all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths | Deaths | 3 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths | Any AEs | 42 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths | Any SAEs | 20 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths | Any AEs | 37 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths | Any SAEs | 20 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths | Deaths | 2 Participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities
Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10\^9/L), Platelets (100 - 550 10\^9/L), Alanine aminotransferase (ALAT) \[0 110 units per litre (U/L)\], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (0 - 80 U/L), Albumin \>= 30 g/L, Phosphate \[0.75 - 1.60 millimoles per liter (mmol/L)\], Potassium (2.9 - 5.8 mmol/L), Glucose (2.80 - 11.10 mmol/L).
Time frame: Up to Week 126
Population: The safety population was considered for analysis which included all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Albumin - Low; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -High; (n = 15, 15, 15, 15 , 16 , 15) | 3 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -Low; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Total Bilirubin-High; (n = 15, 15, 15, 15, 16, 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | ALAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Neutrophils - Low; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Basophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | ASAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -High; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Eosinophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | ALP - High; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 3 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -High; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -Low; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -Low; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Albumin - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Total Bilirubin-High; (n = 15, 15, 15, 15, 16, 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | ASAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | ALP - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -High; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | ALAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Basophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Eosinophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Neutrophils - Low; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 2 (RO0503821 [0.25/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -High; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | ALAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Albumin - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - Low; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Eosinophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -Low; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -Low; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -High; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Basophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | ASAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -High; (n = 15, 15, 15, 15 , 16 , 15) | 3 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - Low; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Total Bilirubin-High; (n = 15, 15, 15, 15, 16, 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | ALP - High; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Neutrophils - Low; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 2 Participants |
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -High; (n = 15, 15, 15, 15 , 16 , 15) | 4 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - Low; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - Low; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Basophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Eosinophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Neutrophils - Low; (n = 15, 15, 14, 15 , 16 , 15) | 1 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | ALAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | ALP - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | ASAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Total Bilirubin-High; (n = 15, 15, 15, 15, 16, 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Albumin - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -High; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -Low; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Eosinophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Total Bilirubin-High; (n = 15, 15, 15, 15, 16, 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Basophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -High; (n = 15, 15, 15, 15 , 16 , 15) | 2 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Albumin - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | ALP - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -Low; (n = 15, 15, 15, 15 , 16 , 15) | 2 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -High; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Neutrophils - Low; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -High; (n = 15, 15, 15, 15 , 16 , 15) | 4 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 2 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | ASAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -Low; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Number of Participants With Marked Laboratory Abnormalities | ALAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Basophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Neutrophils - Low; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -High; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | ALAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | ASAT - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | ALP - High; (n = 15, 15, 15, 15 , 16 , 15) | 1 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Platelets - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | WBC - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Total Bilirubin-High; (n = 15, 15, 15, 15, 16, 15) | 1 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Potassium -High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Glucose Fasting -Low; (n = 5, 6, 9, 6, 6 , 9) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Albumin - Low; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Phosphate -High; (n = 15, 15, 15, 15 , 16 , 15) | 2 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - Low; (n = 15, 15, 15, 15 , 16 , 15) | 3 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Monocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Lymphocytes - High; (n = 15, 15, 15, 15 , 16 , 15) | 0 Participants |
| Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Number of Participants With Marked Laboratory Abnormalities | Eosinophils - High; (n = 15, 15, 14, 15 , 16 , 15) | 0 Participants |