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This single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin | Drug | 7.5mg/kg iv (cycle 3 only) |
| |
| Oxaliplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0-Inf) of 5'-Deoxy-5-fluorouridine 5'-(DFUR) | AUC0-infinity represents the area under the concentration-time curve of the analyte (5'-DFUR) in plasma over the time interval from 0 extrapolated to infinity. The analyte 5'-DFUR, the direct precursor of 5-fluorouracil (5-FU), is considered to be the most important metabolite of capecitabine in plasma. The unit of measure was nanograms per millilitre per hour (ng/mL * hr). | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose. |
| AUC0-inf for Free Platinum | AUC0-infinity represents the area under the concentration-time curve of the analyte (free platinum) in plasma over the time interval from 0 extrapolated to infinity. AUC0-inf for free platinum was calculated for each participant from the concentration-data obtained on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. Free platinum is not bound to plasma proteins and is considered to be the most clinically significant measure of pharmacological and toxicological activity. | Predose , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the 2 hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (0-infinity) of Capecitabine and Its Metabolites (5'-DFCR, 5-FU, and FBAL) | AUC0-infinity represents the area under the concentration-time curve of the analytes (5'-DFCR, 5-FU, and FBAL) in plasma over the time interval from 0 extrapolated to infinity. After oral administration, capecitabine is first metabolized in the liver to 5'-deoxy-5-fluorocytidine (5'-DFCR), which is then converted to 5'-DFUR, and then catalytically activated to 5-FU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton | Ontario | L8V 5C2 | Canada | |||
Not provided
A total of 36 participants were enrolled in this study at three sites in Canada between 8 August 2005 and 24 April 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine+ Oxaliplatin+ Bevacizumab | In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine+ Oxaliplatin+ Bevacizumab | In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0-Inf) of 5'-Deoxy-5-fluorouridine 5'-(DFUR) | AUC0-infinity represents the area under the concentration-time curve of the analyte (5'-DFUR) in plasma over the time interval from 0 extrapolated to infinity. The analyte 5'-DFUR, the direct precursor of 5-fluorouracil (5-FU), is considered to be the most important metabolite of capecitabine in plasma. The unit of measure was nanograms per millilitre per hour (ng/mL * hr). | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL*hr | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose. |
|
Approximately 3 Years (up to 28 days after the last intake of study medication)
Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and includes any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capecitabine+ Oxaliplatin+ Bevacizumab | In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
130mg/m2 iv (cycles 1, 2 and 3) |
|
| capecitabine [Xeloda] | Drug | 1000mg/m2 po bid (cycles 1, 2 and 3) |
|
| Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose |
| AUC0-last of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL) | Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of capecitabine and its metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL). | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose |
| Maximum Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL) | Cmax is defined as maximum observed analyte concentration of capecitabine and its metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose |
| Elimination Half-life Period (t1/2 Beta) of Capecitabine and Its Metabolites (5'-DFUR , 5'-DFCR, 5 FU, and FBAL) | t1/2 Beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of capecitabine and its metabolites (5'-DFUR , 5'-DFCR, 5 FU, and FBAL) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose |
| AUC0-infinity for Total Platinum | AUC0-infinity represents the area under the concentration-time curve of the analyte (total platinum) in plasma over the time interval from 0 extrapolated to infinity. | Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3 |
| AUC0-last of Total And Free Platinum | Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of Total And Free Platinum. | pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. |
| Cmax of Total And Free Platinum | Cmax is defined as maximum observed analyte concentration of Total And Free Platinum. | Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. |
| T1/2 Beta of Total And Free Platinum | T1/2 beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of total and free platinum. | Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3 |
| Volume of Distribution at Steady State (VSS) of Total And Free Platinum | VSS is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours |
| Clearance of Total And Free Platinum | CL is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (hour). | Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3 |
| Number Of Participants With Adverse Events (AEs) | An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. This includes 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. Pre-existing conditions which worsened during the study were also to be reported as AEs. | Approximately 3 Years (up to 28 days after the last intake of study medication) |
| Marked Laboratory Abnormalities | Number of participants with marked laboratory abnormalities (hematology, coagulation, liver function, renal function, protein, electrolytes, miscellaneous). | Up to 28 days after last chemotherapy administration |
| Ottawa |
| Ontario |
| K1H 8L6 |
| Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Progression |
|
| Surgery |
|
| Break from Chemotherapy |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
|
|
|
| Primary | AUC0-inf for Free Platinum | AUC0-infinity represents the area under the concentration-time curve of the analyte (free platinum) in plasma over the time interval from 0 extrapolated to infinity. AUC0-inf for free platinum was calculated for each participant from the concentration-data obtained on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. Free platinum is not bound to plasma proteins and is considered to be the most clinically significant measure of pharmacological and toxicological activity. | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL * hr | Predose , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the 2 hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. |
|
|
|
|
| Secondary | AUC (0-infinity) of Capecitabine and Its Metabolites (5'-DFCR, 5-FU, and FBAL) | AUC0-infinity represents the area under the concentration-time curve of the analytes (5'-DFCR, 5-FU, and FBAL) in plasma over the time interval from 0 extrapolated to infinity. After oral administration, capecitabine is first metabolized in the liver to 5'-deoxy-5-fluorocytidine (5'-DFCR), which is then converted to 5'-DFUR, and then catalytically activated to 5-FU. | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL*hr | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose |
|
|
|
|
| Secondary | AUC0-last of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL) | Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of capecitabine and its metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL). | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL*hr | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL) | Cmax is defined as maximum observed analyte concentration of capecitabine and its metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL) | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose |
|
|
|
|
| Secondary | Elimination Half-life Period (t1/2 Beta) of Capecitabine and Its Metabolites (5'-DFUR , 5'-DFCR, 5 FU, and FBAL) | t1/2 Beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of capecitabine and its metabolites (5'-DFUR , 5'-DFCR, 5 FU, and FBAL) | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose |
|
|
|
| Secondary | AUC0-infinity for Total Platinum | AUC0-infinity represents the area under the concentration-time curve of the analyte (total platinum) in plasma over the time interval from 0 extrapolated to infinity. | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL* hr | Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3 |
|
|
|
|
| Secondary | AUC0-last of Total And Free Platinum | Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of Total And Free Platinum. | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL* hr | pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. |
|
|
|
| Secondary | Cmax of Total And Free Platinum | Cmax is defined as maximum observed analyte concentration of Total And Free Platinum. | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. |
|
|
|
|
| Secondary | T1/2 Beta of Total And Free Platinum | T1/2 beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of total and free platinum. | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3 |
|
|
|
| Secondary | Volume of Distribution at Steady State (VSS) of Total And Free Platinum | VSS is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL | Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours |
|
|
|
| Secondary | Clearance of Total And Free Platinum | CL is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (hour). | All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/Hr | Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3 |
|
|
|
| Secondary | Number Of Participants With Adverse Events (AEs) | An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. This includes 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. Pre-existing conditions which worsened during the study were also to be reported as AEs. | All 36 participants who received at least one dose of capecitabine. | Posted | Number | Participants | Approximately 3 Years (up to 28 days after the last intake of study medication) |
|
|
|
| Secondary | Marked Laboratory Abnormalities | Number of participants with marked laboratory abnormalities (hematology, coagulation, liver function, renal function, protein, electrolytes, miscellaneous). | All 36 participants who received at least one dose of capecitabine. | Posted | Number | Participants | Up to 28 days after last chemotherapy administration |
|
|
|
| 16 |
| 36 |
| 36 |
| 36 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastrooesophageal reflux Disease | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rectal Discharge | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Catheter related complication | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Catheter site rash | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Palmar-plantar | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Erythrodysaesthesia syndrome Dry skin | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
|
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.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| Title | Measurements |
|---|---|
|
| Geometric mean ratio |
| 1.02 |
| 2-Sided |
| 90 |
| 0.98 |
| 1.05 |
| No |
| Superiority or Other |
| Cycle 3, Day 1 to Cycle 2, Day 1 | Geometric mean ratio | 0.97 | 2-Sided | 90 | 0.94 | 1.00 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| 5'-DFCR , Cycle 1, Day 1 |
|
| 5'-DFCR , Cycle 2, Day 1 |
|
| 5'-DFCR, Cylce 3, Day 1 |
|
| 5-FU , Cycle 1, Day 1 |
|
| 5-FU , Cycle 2, Day 1 |
|
| 5-FU , Cycle 3, Day 1 |
|
| FBAL , Cycle 1, Day 1 |
|
| FBAL , Cycle 2, Day 1 |
|
| FBAL , Cycle 3, Day 1 |
|
| Geometric mean ratio |
| 1.16 |
| 2-Sided |
| 90 |
| 0.94 |
| 1.42 |
| No |
| Superiority or Other |
| Capecitabine: Cycle 3, Day 1 to Cycle 1, Day 1 | Geometric mean ratio | 1.17 | 2-Sided | 90 | 0.96 | 1.44 | No | Superiority or Other |
| 5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.86 | 2-Sided | 90 | 0.69 | 1.08 | No | Superiority or Other |
| 5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 1.08 | 2-Sided | 90 | 0.86 | 1.34 | No | Superiority or Other |
| 5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 1.25 | 2-Sided | 90 | 1.00 | 1.55 | No | Superiority or Other |
| 5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.81 | 2-Sided | 90 | 0.66 | 1.01 | No | Superiority or Other |
| 5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.79 | 2-Sided | 90 | 0.64 | 0.97 | No | Superiority or Other |
| 5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 0.97 | 2-Sided | 90 | 0.78 | 1.19 | No | Superiority or Other |
| FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.97 | 2-Sided | 90 | 0.91 | 1.04 | No | Superiority or Other |
| FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.97 | 2-Sided | 90 | 0.90 | 1.04 | No | Superiority or Other |
| FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 1.00 | 2-Sided | 90 | 0.93 | 1.07 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Capecitabine, Cycle 1, Day 1 |
|
| Capecitabine, Cycle 2, Day 1 |
|
| Capecitabine, Cycle 3, Day 1 |
|
| 5'-DFCR, Cycle 1, Day 1 |
|
| 5'-DFCR, Cycle 2 , Day 1 |
|
| 5'-DFCR, Cycle 3, Day 1 |
|
| 5-FU, Cycle 1, Day 1 |
|
| 5-FU, Cycle 2, Day 1 |
|
| 5-FU, Cycle 3, Day 1 |
|
| FBAL, Cycle 1, Day 1 |
|
| FBAL, Cycle 2, Day 1 |
|
| FBAL, Cycle 3, Day 1 |
|
| Title | Measurements |
|---|---|
|
| Capecitabine, Cycle 1, Day 1 |
|
| Capecitabine, Cycle 2, Day 1 |
|
| Capecitabine, Cycle 3, Day 1 |
|
| 5' DFCR, Cycle 1, Day 1 |
|
| 5' DFCR, Cycle 2, Day 1 |
|
| 5' DFCR , Cycle 3, Day 1 |
|
| 5-FU, Cycle 1 , Day 1 |
|
| 5-FU, Cycle 2, Day 1 |
|
| 5-FU, Cycle 3, Day 1 |
|
| FBAL, Cycle 1, Day 1 |
|
| FBAL, Cycle 2, Day 1 |
|
| FBAL, Cycle 3, Day 1 |
|
| Geometric mean ratio |
| 0.64 |
| 2-Sided |
| 90 |
| 0.53 |
| 0.79 |
| No |
| Superiority or Other |
| 5'-DFUR: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 0.87 | 2-Sided | 90 | 0.71 | 1.06 | No | Superiority or Other |
| Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.82 | 2-Sided | 90 | 0.63 | 1.08 | No | Superiority or Other |
| Capecitabine: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 1.03 | 2-Sided | 90 | 0.78 | 1.34 | No | Superiority or Other |
| Capecitabine: Cycle 3, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.85 | 2-Sided | 90 | 0.65 | 1.10 | No | Superiority or Other |
| 5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.87 | 2-Sided | 90 | 0.65 | 1.18 | No | Superiority or Other |
| 5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.96 | 2-Sided | 90 | 0.71 | 1.30 | No | Superiority or Other |
| 5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 1.10 | 2-Sided | 90 | 0.81 | 1.49 | No | Superiority or Other |
| 5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.74 | 2-Sided | 90 | 0.56 | 0.98 | No | Superiority or Other |
| 5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.58 | 2-Sided | 90 | 0.44 | 0.76 | No | Superiority or Other |
| 5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 0.78 | 2-Sided | 90 | 0.59 | 1.03 | No | Superiority or Other |
| FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.91 | 2-Sided | 90 | 0.83 | 1.00 | No | Superiority or Other |
| FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1 | Geometric mean ratio | 0.83 | 2-Sided | 90 | 0.76 | 0.91 | No | Superiority or Other |
| FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 0.91 | 2-Sided | 90 | 0.83 | 1.00 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Capecitabine, Cycle 1, Day 1 |
|
| Capecitabine, Cycle 2, Day 1 |
|
| Capecitabine, Cycle 3, Day 1 |
|
| 5'-DFCR, Cycle 1, Day 1 |
|
| 5'-DFCR, Cycle 2 , Day 1 |
|
| 5'-DFCR, Cycle 3, Day 1 |
|
| 5-FU, Cycle 1, Day 1 |
|
| 5-FU, Cycle 2, Day 1 |
|
| 5-FU, Cycle 3, Day 1 |
|
| FBAL, Cycle 1, Day 1 |
|
| FBAL, Cycle 2, Day 1 |
|
| FBAL, Cycle 3, Day 1 |
|
| Title | Measurements |
|---|---|
|
| Geometric mean ratio |
| 1.34 |
| 2-Sided |
| 90 |
| 1.21 |
| 1.48 |
| No |
| Superiority or Other |
| Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 1.11 | 2-Sided | 90 | 1.01 | 1.23 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Free Platinum: Cycle 1, Day 2 |
|
| Free Platinum: Cycle 2, Day 1 |
|
| Free Platinum: Cycle 3, Day 1 |
|
| Title | Measurements |
|---|---|
|
| Free Platinum: Cycle 1, Day 2 |
|
| Free Platinum: Cycle 2, Day 1 |
|
| Free Platinum: Cycle 3, Day 1 |
|
| Geometric mean ratio |
| 1.01 |
| 2-Sided |
| 90 |
| 0.95 |
| 1.08 |
| No |
| Superiority or Other |
| Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 0.99 | 2-Sided | 90 | 0.93 | 1.05 | No | Superiority or Other |
| Free Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2 | Geometric mean ratio | 1.01 | 2-Sided | 90 | 0.94 | 1.09 | No | Superiority or Other |
| Free Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2 | Geometric mean ratio | 1.00 | 2-Sided | 90 | 0.92 | 1.08 | No | Superiority or Other |
| Free Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1 | Geometric mean ratio | 0.99 | 2-Sided | 90 | 0.91 | 1.07 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Free Platinum: Cycle 1, Day 2 |
|
| Free Platinum: Cycle 2, Day 1 |
|
| Free Platinum: Cycle 3, Day 1 |
|
|
| Free Platinum: Cycle 1, Day 2 |
|
| Free Platinum: Cycle 2, Day 1 |
|
| Free Platinum: Cycle 3, Day 1 |
|
| Title | Measurements |
|---|---|
|
| Free Platinum: Cycle 1, Day 2 |
|
| Free Platinum: Cycle 2, Day 1 |
|
| Free Platinum: Cycle 3, Day 1 |
|
| Title | Measurements |
|---|---|
|
| Platelets - high |
|
| Platelets - low |
|
| RBC - low |
|
| WBC - high |
|
| WBC - low |
|
| Neutrophils - high |
|
| Neutrophils - low |
|
| PT (INR) - high |
|
| ASAT (SGOT) - high |
|
| LDH - high |
|
| ALAT (SGPT) - high |
|
| Alk. Phos. - high |
|
| Dir. Bilirubin - high |
|
| Total Bilirubin - high |
|
| Creatinine - high |
|
| Albumin - low |
|
| Potassium - low |
|
| Sodium - low |
|
| Calcium - low |
|
| Glucose Fasting - high |
|