Study Subject Dropouts Due to an Adverse Drug Experience A narrative or tabular summary of all of subjects who dropped out during the course of the investigation in association with any adverse experience, whether or not thought to be drug related, during the past year. An example of a reporting table is below. have been no subjects who have discontinued the treatment/study due intolerable adverse events. A summary of subjects who were discontinued prematurely from the study due to an adverse event is presented in the table below. Subject Date of Reason for Discontinuation ID Discontinuation Understanding of the Drug’s Action A description of what, if anything, was obtained that is pertinent to an understanding of the drug's actions, including, for example, information about dose response, information from controlled trials, and information about bioavailability. As of this report date, is no new information/no articles have been published] in relation to this study. The following new information was obtained during the reporting period in relation to this study: List of Preclinical Studies A list of the preclinical studies (including animal studies) completed or in progress during the past year and a summary of the major preclinical findings. As of this report date, there have not been any [additional/new] preclinical studies [started/completed]. As of this report date, the following preclinical studies were [initiated/completed]: Summary of Manufacturing or Microbiological Changes A summary of any significant manufacturing or microbiological changes made during the past year. There were no manufacturing or microbiological changes during the reporting period. A summary of the significant manufacturing/microbiological changes includes:
Study Subject Dropouts Due to an Adverse Drug Experience A narrative or tabular summary of all of subjects who dropped out during the course of the investigation in association with any adverse experience, whether or not thought to be drug related, during the past year. An example of a reporting table is below. have been no subjects who have discontinued the treatment/study due intolerable adverse events. A summary of subjects who were discontinued prematurely from the study due to an adverse event is presented in the table below. Subject ID Date of Discontinuation Reason for Discontinuation Understanding of the Drug’s Action A description of what, if anything, was obtained that is pertinent to an understanding of the drug's actions, including, for example, information about dose response, information from controlled trials, and information about bioavailability. As of this report date, is no new information/no articles have been published] in relation to this study. The following new information was obtained during the reporting period in relation to this study: List of Preclinical Studies A list of the preclinical studies (including animal studies) completed or in progress during the past year and a summary of the major preclinical findings. As of this report date, there have not been any [additional/new] preclinical studies [started/completed]. As of this report date, the following preclinical studies were [initiated/completed]: Summary of Manufacturing or Microbiological Changes A summary of any significant manufacturing or microbiological changes made during the past year. There were no manufacturing or microbiological changes during the reporting period. A summary of the significant manufacturing/microbiological changes includes:
IND_Annual_Report_Template-2018_02_06.docx