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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002478-23 | EudraCT Number |
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This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin detemir | Experimental | Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Detemir-insulin Aspart Cross-reacting Antibodies | Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection. | week 0, 52 and 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies | Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks. | At 0, 52 and 104 weeks |
| Glycosylated Haemoglobin A1c (HbA1c) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Pleven | 5800 | Bulgaria | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27600385 | Background | Thalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. doi: 10.1007/s13300-016-0196-5. Epub 2016 Sep 6. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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At entry subjects had finalised 52-weeks treatment with insulin detemir plus insulin aspart (Trial NN304-1689, NCT00435019). Subjects treated with NPH insulin plus insulin aspart in trial NN304-1689 were not offered to continue in this extension trial. Subjects continued treatment with insulin detemir and insulin aspart doses from trial NN304-1689.
29 sites in 11 countries: (Bulgaria (3 sites), Czech Republic (3 sites), Denmark (2 sites), Finland (4 sites), France (1 site), Hungary (2 sites), Macedonia (1 site), Poland (4 sites), Russian Federation (4 sites), Turkey (4 sites) and United Kingdom (1 site)
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Detemir | Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| insulin aspart | Drug | Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals. |
|
Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks. |
| At 104 weeks |
| Fasting Plasma Glucose Values | FPG (Fasting Plasma Glucose) values after 104 weeks. | At 104 weeks |
| Hypoglycaemic Episodes | Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment. Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment. | Weeks 0-104 |
| BMI (Body Mass Index) | BMI (Body Mass Index) after 104 weeks. | At 104 weeks |
| SD-score (Z-score) for Body Weight | Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. | At 104 weeks |
| Diabetic Ketoacidosis | Diabetic ketoacidosis requiring hospitalisation | At 104 weeks |
| Insulin Dose | Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104. | At 104 weeks |
| Laboratory Values: Albumin Serum and Total Protein Serum (g/dL) | Albumin Serum and Total Protein Serum after 104 weeks. | At 104 weeks |
| Laboratory Values: Creatine Serum Umol/L | Creatine serum after 104 weeks. | At 104 weeks |
| Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L) | Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks. | At 104 weeks |
| Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L) | Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks. | At 104 weeks |
| Laboratory Values: Leukocytes and Thrombocytes | Leukocytes and Thrombocytes after 104 weeks. | At 104 weeks |
| Fundoscopy/Fundus Photography | Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant | at 52 weeks and at 104 weeks |
| Vital Signs: Blood Pressure | Blood pressure (Systolic and Diastolic) after 104 weeks. | At 104 weeks |
| Vital Signs: Pulse | Pulse at week 104 | At 104 weeks |
| Sofia |
| 1606 |
| Bulgaria |
| Novo Nordisk Investigational Site | Varna | 9010 | Bulgaria |
| Novo Nordisk Investigational Site | Olomouc | 77520 | Czechia |
| Novo Nordisk Investigational Site | Pardubice | 53203 | Czechia |
| Novo Nordisk Investigational Site | Prague | 15018 | Czechia |
| Novo Nordisk Investigational Site | Glostrup Municipality | 2600 | Denmark |
| Novo Nordisk Investigational Site | Kolding | 6000 | Denmark |
| Novo Nordisk Investigational Site | Odense | 5000 | Denmark |
| Novo Nordisk Investigational Site | Helsinki | 00029 | Finland |
| Novo Nordisk Investigational Site | Oulu | 90029 | Finland |
| Novo Nordisk Investigational Site | Seinäjoki | 60220 | Finland |
| Novo Nordisk Investigational Site | Turku | 20100 | Finland |
| Novo Nordisk Investigational Site | Paris | 75015 | France |
| Novo Nordisk Investigational Site | Toulouse | 31059 | France |
| Novo Nordisk Investigational Site | Budapest | 1083 | Hungary |
| Novo Nordisk Investigational Site | Miskolc | 3501 | Hungary |
| Novo Nordisk Investigational Site | Skopje | 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Gdansk | 80-211 | Poland |
| Novo Nordisk Investigational Site | Kielce | 25-734 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 01-184 | Poland |
| Novo Nordisk Investigational Site | Moscow | 117036 | Russia |
| Novo Nordisk Investigational Site | Moscow | 119049 | Russia |
| Novo Nordisk Investigational Site | Moscow | 125373 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 193144 | Russia |
| Novo Nordisk Investigational Site | Altunizade-Istanbul | 34662 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Antalya | 07059 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34093 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Izmir | 35340 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Aberdeen | AB25 2ZG | United Kingdom |
| Novo Nordisk Investigational Site | Dundee | DD1 9SY | United Kingdom |
| Novo Nordisk Investigational Site | Norfolk | NR4 7UY | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Detemir | Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at entry in NN304-1689 (NCT00435019) | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age | Number of subjects in each age group at entry in NN304-1689 (NCT00435019) | Number | participants |
| ||||||||||||||||||||||
| Height | Height at entry in NN304-1689 (NCT00435019) | Mean | Standard Deviation | meters |
| |||||||||||||||||||||
| BMI | Body Mass Index (BMI) at entry in NN304-1689 (NCT00435019) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||||||
| Pubertal Status | Tanner scale: Pre-pubertal: Tanner grade 1: the vellus over the pubes is not further developed than that over the abdominal wall, i.e. no pubic hair. Pubertal: Tanner grade 2 or more: sparse growth of long slightly pigmented downy hair, straight, or slightly curled, chiefly at base of penis or along labia. | Number | participants |
|
| 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 | Insulin Detemir-insulin Aspart Cross-reacting Antibodies | Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection. | Full analysis set 146 (100%), safety analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension. The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Error | Percent bound of total | week 0, 52 and 104 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies | Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension period. | Posted | Mean | Standard Error | Percent bound of total | At 0, 52 and 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Glycosylated Haemoglobin A1c (HbA1c) | Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks. | Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension. | Posted | Mean | Standard Deviation | Percent (%) glycosylated haemoglobin | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Plasma Glucose Values | FPG (Fasting Plasma Glucose) values after 104 weeks. | Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension. | Posted | Mean | Standard Deviation | mmol/L | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Hypoglycaemic Episodes | Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment. Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Number | events | Weeks 0-104 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | BMI (Body Mass Index) | BMI (Body Mass Index) after 104 weeks. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Deviation | kg/m^2 | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | SD-score (Z-score) for Body Weight | Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Deviation | SD-scores | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Diabetic Ketoacidosis | Diabetic ketoacidosis requiring hospitalisation | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Number | events | At 104 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Insulin Dose | Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Deviation | U/kg | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Values: Albumin Serum and Total Protein Serum (g/dL) | Albumin Serum and Total Protein Serum after 104 weeks. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Deviation | g/dL | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Values: Creatine Serum Umol/L | Creatine serum after 104 weeks. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Deviation | Umol/L | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L) | Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Deviation | mmol/L | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L) | Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Deviation | U/L | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Values: Leukocytes and Thrombocytes | Leukocytes and Thrombocytes after 104 weeks. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Deviation | 10^9/L | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Fundoscopy/Fundus Photography | Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Number | participants | at 52 weeks and at 104 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Vital Signs: Blood Pressure | Blood pressure (Systolic and Diastolic) after 104 weeks. | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Deviation | mmHg | At 104 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Vital Signs: Pulse | Pulse at week 104 | The safety analysis set included all subjects with a signed informed consent who were exposed in the extension. | Posted | Mean | Standard Deviation | beats/minute | At 104 weeks |
|
|
The adverse events were collected over a period of 104 weeks.
The safety analysis set is all subjects exposed to at least one dose of trial drug.
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 | Insulin Detemir | Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks) | 12 | 146 | 108 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Gastroenteritis shigella | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Hypoglycaemia unconsciousness | Metabolism and nutrition disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Burns second degrees | Injury, poisoning and procedural complications | MedDRA version 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Acute Tonsilliitis | Infections and infestations | MedDRA version 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 11.1 | Systematic Assessment |
|
Novo Nordisk reserves the right not to release data until specified milestones, e.g., a Clinical Trial Report is available. At the end of the trial, one or more manuscripts for publication will be prepared in collaboration between authors and Novo Nordisk. Novo Nordisk will not suppress or veto publications; however Novo Nordisk reserves the right to postpone publication and/or communication for a short time to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 13-16 years |
|
| Title | Measurements |
|---|---|
|
| Week 0 (2.5 hours) |
|
| Week 52 (2.5 hours) |
|
| Week 104 (2.5 hours) |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Insulin Detemir dose (Basal) |
| |||||
| Insulin Aspart dose (Bolus) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Albumin serum (n=144) |
| |||||
| Total Protein serum (n=144) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Sodium Serum (n=144) |
| |||||
| Potassium serum (n=137) |
| |||||
| Haemoglobin (n=144) |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Leukocytes (n=144) |
| |||||
| Thrombocytes (n=144) |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Systolic Blood Pressure |
| |||||
| Diastolic Blood Pressure |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|