Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study, For treatment- emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequence.
Safety Analysis Set. All randomized subjects who take at least 1 dose of KPL-716 or placebo will be included in the Safety Analysis Set.
Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study. Therefore, any AE or device deficiency occurring after Informed Consent and prior to the initial exposure to the study lenses (test or comparator) under evaluation in this clinical protocol will be listed as pretreatment. For treatment-emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequence.
Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses (DACP FreshTech or DACP) evaluated in this study. The optimized habitual lenses and trial- fit lenses are not considered study lenses for the purpose of safety evaluation. For treatment- emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequence.
Safety Analysis Set. The safety analysis set will include all patients who received at least 1 dose of AZD5363/matching placebo. Any patient who only receives one or more doses of paclitaxel and does not commence dosing with AZD5363/matching placebo will not be included in the assessment of safety data. The safety analysis set will be the primary set used for the safety analyses. Patients in the safety analysis set will be analysed by actual treatment initially received. If patients were dose reduced during the study, all data will be summarised/analysed based on the initial dose of study treatment received. However, some listings such as adverse event (AE) listings may give the actual dose the patient received at the time of the AE (e.g. dose interruption etc).
Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study, For treatment-emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequence. Subjects who are lost to follow-up and their exposure to dispensed study lenses is unknown will be included in the safety analysis data set. The visit date for Dispense (Lens 1 or Lens 2) will be used as the first exposure date for the respective Lens.
Safety Analysis Set. The safety analysis set will include all patients who receive any part of an infusion of study drug.
