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Hot Flashes Study Sections
 Author Bio
Introduction 
Commentator Bio
Protocol Schema
Protocol Background
Protocol Goals
Patient Eligibility
Test Schedule
Stratification Factors
Registration/Randomization
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Currently selected section: Dosage Modification
Ancillary Treatment
Toxicity Monitoring
Treatment Evaluation
Descriptive Factors
Treatment/Follow-up
Pharmacologic Studies
Drug Information
Statistical Considerations
Pathology Considerations
Records/Data Collection Procedures
Budget
Appendices

 

Chapter 2B: Development of a Clinical Trial for Hot Flash Protocol: Dosage Modification
 

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8.0 No significant toxicity is expected from the study medication. However, if the patient develops any symptoms attributed to the medication which are considered by the patient and/or physician to be of unacceptable severity, then the patient will be taken off study. Any of the above should be clearly recorded on the Nurse's Work Sheet (Appendix V or Appendix VII).


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