Trial · NCT00736099
Registered outcomes46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 46
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Patients With Adverse Events (AEs) | 78 weeks | This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures. |
| Primary | Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events | 78 weeks | |
| Primary | Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ) | 78 weeks | As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis''). |
| Primary | Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events | 78 weeks | Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC) |
| Primary | Number of Patients With Abnormalities in Vital Signs | 78 weeks | Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events) |
| Primary | Number of Patients With Abnormalities in Haematology: Eosinophils | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%. |
| Primary | Number of Patients With Abnormalities in Haematology: Haemoglobin | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients. |
| Primary | Number of Patients With Abnormalities in Haematology: Haematocrit | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%. |
| Primary | Number of Patients With Abnormalities in Haematology: Red Blood Cell Count | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^12/L. |
| Primary | Number of Patients With Abnormalities in Haematology: White Blood Cell Count | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^9/L (decrease) or a value greater than 20.1 \* 10\^9/L (increase). |
| Primary | Number of Patients With Abnormalities in Haematology: Platelets | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 \* 10\^9/L (decrease) or a value greater than or equal to 700 \* 10\^9/L (increase). |
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Potassium | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase). |
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients. |
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL. |
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Amylase | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN). |
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT) | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. |
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Creatinine | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL. |
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. |
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Phosphate | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase). |
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Calcium | 78 weeks | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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