Safety Analyses. The safety endpoints are: AEs Biomicroscopy findings Device deficiencies There are no safety hypotheses planned in this study. The focus of the safety analysis will be a comprehensive descriptive assessment of occurrence of AEs as well as the other listed parameters. All AEs occurring from the time a subject signs informed consent to study exit will be accounted for in the reporting. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to study discontinuation, significant nonserious AEs, and SAEs will be identified. Individual subject listings will be provided, as necessary. Individual subject listings will be provided for AEs that occur after signing informed consent but prior to exposure to IP. Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from baseline (last assessment prior to study lens exposure) to any subsequent visit within the same period will be presented. A supportive listing will be generated which will include all biomicroscopy data from all visits within the same period for those eyes experiencing the increase. Two listings for device deficiencies, prior to exposure of study contact lenses and treatment-emergent, will be provided. Additionally, each device deficiency category will be tabulated. No inferential testing will be done for safety analysis.
Safety Analyses. Safety analyses will be performed using the Safety Analysis Set.
Safety Analyses. The safety endpoints are: • AEs • Biomicroscopy Findings • Device Deficiencies There are no safety hypotheses planned in this study. The focus of the safety analysis will be a comprehensive descriptive assessment of occurrence of AE as well as the other listed parameters. All AEs occurring from the time a subject signs informed consent to study exit will be accounted for in the reporting. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and SAEs will be identified. Individual subject listings will be provided, as necessary. Individual subject listings will be provided for AEs that occur after signing informed consent but prior to exposure to IP. Two listings for device deficiencies, prior to exposure of study contact lenses and treatment- emergent, will be provided. Additionally, each device deficiency category will be tabulated. No inferential testing will be done for safety analysis.
Safety Analyses. The safety endpoints are: • AEs • Biomicroscopy findings • Device deficiencies There are no safety hypotheses planned in this study. The focus of the safety analysis will be a comprehensive descriptive assessment of occurrence of AE as well as the other listed parameters. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms, for Completed and Discontinued sets. A listing containing details of the AEs will also be provided. Each biomicroscopy parameter will be tabulated by its grade, on Completed and Discontinued analysis sets. Frequency for each device deficiency category will be presented and a supporting listing will be provided.
Safety Analyses. Actions to be taken following the communication of the new sample size will depend on the new sample size, as detailed below: New Sample Size Action Smaller than or equal to 66 No changes and complete the study with the originally planned sample size of 66 completers Larger than 66 but smaller or equal than 90 Update and complete the study as per new sample size requirement Larger than 90 No changes and complete the study with the originally planned sample size of 66 completers
Safety Analyses. The safety population will be based on the treated population, and will be analyzed according to the actual treatment received. Data collected on all subjects who were randomized but did not receive study drug will be listed and summarized, if appropriate.
Safety Analyses. The Contractor shall establish and maintain a Safety Program to ensure that the spacecraft and all units and subsystems are capable of being manufactured, stored, handled, transported, installed, and tested safely during all Contract phases. The details of the program shall be included in the Product Assurance Plan. Asterisks (“**”) indicate omitted material pursuant to a request for confidential treatment INTEL-2400 APPENDIX 3 TO EXHIBIT B REVISION 2 The safety analyses shall include consideration of safety provisions for all spacecraft equipment at all times prior to launch, during launch vehicle abort, and during emergency launch vehicle operations. Particular attention shall be given to ground support equipment handling aspects. Safety data and analyses shall be provided at the relevant CDRs. In addition, safety data and analyses shall be provided as required by the launch vehicle agencies. Asterisks (“**”) indicate omitted material pursuant to a request for confidential treatment Amendment No.3 INTEL-2400 EXHIBIT D INTELSAT TEST PLAN REVISION 2 Asterisks (“**”) indicate omitted material pursuant to a request for confidential treatment Amendment No.3 INTEL-2400 ********* ********* 238 pages of revised Exhibit D have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. Asterisks (“**”) indicate omitted material pursuant to a request for confidential treatment Amendment No.3 INTEL-2400 EXHBIT F – REVISION 2 INTELSAT X MILESTONE PAYMENT PLAN January 2003 - 13 - Asterisks (“**”) indicate omitted material pursuant to a request for confidential treatment Amendment No.3 INTEL-2400 *********** ************ ************* 27 pages of revised Exhibit F have been omitted and file separately with the Securities and Exchange Commission Pursuant to a request for confidential treatment.
Safety Analyses. All safety summaries and analyses will be based upon the Safety Population as defined in Section 13.1. Overall exposure to study drug, the numbers of patients completing each cycle, and the will be summarized using descriptive statistics. An overall summary of AEs will be provided for AEs deemed by the investigator to be possibly related to study drug, and for all causalities. A treatment-emergent adverse event (TEAE) is defined as an event that first occurred or worsened in severity after baseline. The number of patients who experienced a TEAE, SAE, TEAE related to study drug, died, or discontinued from the study due to an AE will be summarized by treatment. Common Terminology Criteria for Adverse Events v 5.0 will be used when reporting AEs by CTCAE terms. Laboratory and non-laboratory CTCAEs will be summarized by CTCAE term and maximum CTCAE grade, including the total for maximum Grade 3 and 4. These summaries will be provided for events regardless of study drug causality, and for events deemed by the investigator to be possibly related to study medication. Reasons for death will be summarized separately for on-therapy and within 30 days of last dose of study drug. Serious adverse events will be summarized by PT. Hospitalizations and transfusions during the study treatment period or during the 30-day follow-up period will be summarized by treatment group.
Safety Analyses. All safety data will be populated in the individual CRFs. All safety data will be listed by subjects. Adverse events will be coded using the most current version of Medical Dictionary for Regulatory Activities (MedDRA) summarized by treatment for the number of subjects reporting the treatment emergent adverse event (TEAE) and the number of TEAEs reported. A by-subject AE data listing including verbatim term, coded term, treatment, severity, and relationship to population will be provided. Safety data including ECGs, xxxxx xxxxx assessments and clinical laboratory results, will be summarized by population and point of time of collection. Descriptive statistics using appropriate summary statistics will be calculated for quantitative safety data as well as for the difference to baseline, when appropriate. In addition, a shift table describing out of normal range shifts will be provided for clinical laboratory results. Concomitant medications will be listed by subject and coded using the most current version of WHO drug dictionary. Medical history will be listed by subject.
Safety Analyses. All adverse events and device related adverse events will be presented as the number of subjects reporting each event.
