Adverse events levels

Type of adverse event Level of investigation Internal resources External bodies who may investigate... 

ADCC. Cetuximab is approved for treatment of metastatic colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN). Interestingly, an adverse event, acneiform rash seems to correlate with a better response to cetuximab, while there is no such correlation with expression levels of EGFR assessed by immunohistochemistry. Further side effects are rare infusion reactions and hypomagnesia. Two other anti-EGFR antibodies approved for clinical use are the fully human antibody panitumumab (Vectibix)... 

Study and control groups. Investigators need to consider whether the adverse events that occur are due to abnormalities in the distribution, metabolism, and excretion of drugs as a result of underlying disease. These analyses could be systematically facilitated by having standardized ways of measuring blood (and in some cases, tissue) levels of drugs and their metabolites. 

A statin combined with a resin results in similar reductions in LDL cholesterol as those seen with ezetimibe. However, the magnitude of triglyceride reduction is less with a resin compared to ezetimibe, and this should be considered in patients with higher baseline triglyceride levels. In addition, gastrointestinal adverse events and potential drug interactions limit the utility of this combination. 

The adverse event for a patient may indicate a medical condition such as hypercholestimia, so there may be a request to ensure that there are elevated cholesterol laboratory data to verify such a claim. You can sometimes make this kind of verification with programming if you know precisely which lab tests are involved and what level indicates a probable adverse event. 

The Medical Dictionary for Regulatory Activities (MedDRA) is a creation of the International Conference on Harmonization, and it is used to categorize and code diseases, disorders, and adverse events. The five levels and associated codes to the MedDRA coding hierarchy are as follows ... 

The final meddra data set in this program contains the lower-level term code (llt code) that can then be merged with the adverse events or medical conditions database. By merging the MedDRA dictionary data with the disease data, you can match the verbatim event text captured on the case report form with the preferred term and associated body system. Then you can summarize these data by body system and preferred term you will see an example of this in Chapter 5. 

Our human health depends on a balanced and buffered blood pH. For instance, human blood is slightly basic with a pH between 7.3 and 7.5. If the blood pH drops below 7.3, acidosis occurs. If the blood pH rises above 7.5, alkalosis occurs. Adverse events including death will occur if a significant change in the blood pH goes below 6.8 or above 7.8. pH levels in blood are frequently determined in clinical laboratories [145],... 

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