{"component": "clause", "props": {"groups": [{"samples": [{"hash": "5oQUSnf3t4e", "uri": "/contracts/5oQUSnf3t4e#analysis-sets", "label": "Investigator Agreement", "score": 31.7412259879, "published": true}], "snippet_links": [{"key": "informed-consent-form", "type": "clause", "offset": [79, 100]}, {"key": "exposed-to", "type": "definition", "offset": [172, 182]}, {"key": "the-study", "type": "definition", "offset": [358, 367]}], "snippet": "Five analysis sets will be defined:\na) All Enrolled \u2013 all subjects signing the informed consent form\nb) Enrolled Dispensed \u2013 subjects/eyes from All Enrolled that have been exposed to study lenses\nc) Enrolled Not Dispensed \u2013 subjects/eyes from All Enrolled that have not been exposed to study lenses\nd) Completed \u2013 Enrolled Dispensed subjects/eyes completing the study e) Discontinued \u2013 Enrolled Dispensed subjects/eyes not completing the study", "size": 2, "hash": "23a66a290468bb6fec51df973d45442f", "id": 1}, {"samples": [{"hash": "kuKsQLah8Bm", "uri": "/contracts/kuKsQLah8Bm#analysis-sets", "label": "Investigator Agreement", "score": 34.4165087184, "published": true}], "snippet_links": [{"key": "prior-to", "type": "definition", "offset": [34, 42]}, {"key": "in-addition-to-the", "type": "clause", "offset": [67, 85]}, {"key": "listed-below", "type": "clause", "offset": [100, 112]}, {"key": "exploratory-analyses", "type": "clause", "offset": [122, 142]}], "snippet": "All analysis sets will be defined prior to final database closure. In addition to the analysis sets listed below, further exploratory analyses may be performed using other subgroups of patients.", "size": 1, "hash": "f03ff51346eabe559ff7e617724a0e53", "id": 2}, {"samples": [{"hash": "31GYIqfVD76", "uri": "/contracts/31GYIqfVD76#analysis-sets", "label": "Investigator Agreement", "score": 30.3025907384, "published": true}], "snippet_links": [{"key": "informed-consent-form", "type": "clause", "offset": [79, 100]}, {"key": "exposed-to", "type": "definition", "offset": [172, 182]}, {"key": "prior-to", "type": "definition", "offset": [230, 238]}, {"key": "the-study", "type": "definition", "offset": [474, 483]}, {"key": "complete-the", "type": "clause", "offset": [539, 551]}], "snippet": "Five analysis sets will be defined:\na) All Enrolled \u2013 all subjects signing the informed consent form\nb) Enrolled Dispensed \u2013 subjects/eyes from All Enrolled that have been exposed to study lenses (not considering trial-fit lenses prior to randomization)\nc) Enrolled Not Dispensed \u2013 subjects/eyes from All Enrolled that have not been exposed to study lenses (not considering trial-fit lenses prior to randomization)\nd) Completed \u2013 Enrolled Dispensed subjects/eyes completing the study e) Discontinued \u2013 Enrolled Dispensed subjects/eyes not complete the study", "size": 1, "hash": "3d497acbef01405ac60f0fe0fe2a40c7", "id": 3}, {"samples": [{"hash": "cJUdrOVQfqh", "uri": "/contracts/cJUdrOVQfqh#analysis-sets", "label": "Statistical Agreement", "score": 27.1448751188, "published": true}], "snippet_links": [{"key": "definition-of", "type": "clause", "offset": [4, 17]}, {"key": "intention-to-treat", "type": "definition", "offset": [38, 56]}], "snippet": "2.1 Definition of analysis sets\n2.1.1 Intention to treat (ITT)", "size": 1, "hash": "1245563a17616ea21ae8e22ef00c85a8", "id": 4}, {"samples": [{"hash": "1ecjqL7mBM7", "uri": "/contracts/1ecjqL7mBM7#analysis-sets", "label": "Investigator Agreement", "score": 30.3239388231, "published": true}], "snippet_links": [{"key": "safety-analysis-set", "type": "clause", "offset": [48, 67]}, {"key": "exposed-to", "type": "definition", "offset": [94, 104]}, {"key": "time-of-the", "type": "clause", "offset": [204, 215]}, {"key": "clinical-assessment", "type": "definition", "offset": [216, 235]}], "snippet": "Only 1 analysis set will be defined, namely the safety analysis set. It will include all eyes exposed to any study lenses evaluated in this study. Eyes will be analyzed based upon the lens exposed at the time of the clinical assessment.", "size": 1, "hash": "a82e4e001f7d7cab4ba7176289d6c698", "id": 5}, {"samples": [{"hash": "2xPWSje1fTy", "uri": "/contracts/2xPWSje1fTy#analysis-sets", "label": "Investigator Protocol Agreement", "score": 31.5449436858, "published": true}], "snippet_links": [{"key": "analysis-populations", "type": "clause", "offset": [4, 24]}, {"key": "the-primary", "type": "clause", "offset": [43, 54]}, {"key": "study-drug", "type": "definition", "offset": [201, 211]}, {"key": "the-study", "type": "definition", "offset": [501, 510]}, {"key": "safety-population", "type": "clause", "offset": [620, 637]}, {"key": "per-protocol-population", "type": "clause", "offset": [711, 734]}, {"key": "drug-treatment", "type": "definition", "offset": [822, 836]}], "snippet": "The analysis populations are as follows: \u2022 The primary analysis population is the modified intent-to-treat (mITT) population, which will include all randomized subjects who received at least 1 dose of study drug and have baseline and at least 1 post-baseline virology measurement. The primary analysis will also be performed on the per-protocol population of patients who completed treatment without a major protocol deviation. \u2022 The PK population will include subjects who receive at least 1 dose of the study drug and have sufficient concentration data to support accurate estimation of at least 1 PK parameter. \u2022 The safety population will include all subjects who receive at least 1 dose of study drug. \u2022 A per protocol population will include the subset of the modified intent-to-treat population who completed study drug treatment without a major protocol violation.", "size": 1, "hash": "540af0d732a137c1dae5acd33d9a0fd4", "id": 6}, {"samples": [{"hash": "lwda8urR0lR", "uri": "/contracts/lwda8urR0lR#analysis-sets", "label": "Clinical Study Protocol", "score": 28.0771108958, "published": true}], "snippet_links": [{"key": "analysis-population", "type": "clause", "offset": [18, 37]}, {"key": "the-safety", "type": "clause", "offset": [39, 49]}, {"key": "all-patients", "type": "definition", "offset": [70, 82]}, {"key": "in-the-study", "type": "clause", "offset": [100, 112]}], "snippet": "There will be one analysis population, the Safety set, which includes all patients who are enrolled in the study and receive at least 1 dose of eteplirsen.", "size": 1, "hash": "691c3b4c304bdd23e8385e16bb1da4bf", "id": 7}, {"samples": [{"hash": "b97cChpRyTx", "uri": "/contracts/b97cChpRyTx#analysis-sets", "label": "Investigator Agreement", "score": 25.4465006512, "published": true}], "snippet_links": [{"key": "all-patients", "type": "definition", "offset": [44, 56]}, {"key": "at-enrollment", "type": "clause", "offset": [90, 103]}, {"key": "study-drug", "type": "definition", "offset": [153, 163]}, {"key": "safety-analysis-set", "type": "clause", "offset": [169, 188]}, {"key": "full-analysis-set", "type": "clause", "offset": [259, 276]}], "snippet": "The set of randomized patients will include all patients randomly assigned to a treatment at enrollment, regardless of whether or not a patient took any study drug. The safety analysis set will include all patients who took at least 1 dose of study drug. The full analysis set will include all patients in the safety analysis set.", "size": 1, "hash": "41e475091eac156f1e398356f96f891b", "id": 8}, {"samples": [{"hash": "8j6ihIdwS37", "uri": "/contracts/8j6ihIdwS37#analysis-sets", "label": "Investigator Protocol Agreement", "score": 29.4681777999, "published": true}], "snippet_links": [{"key": "analysis-populations", "type": "clause", "offset": [4, 24]}, {"key": "part-1", "type": "clause", "offset": [224, 230]}, {"key": "study-drug", "type": "definition", "offset": [286, 296]}, {"key": "safety-population", "type": "clause", "offset": [349, 366]}], "snippet": "The analysis populations are as follows: \u2022 The PK population will include subjects who receive at least 1 dose of aramchol and have sufficient concentration data to support accurate estimation of at least 1 PK parameter. In Part 1, subjects who experience vomiting within 6 hours after study drug dosing will be excluded from the PK analysis. \u2022 The safety population will include all subjects who receive at least 1 dose of aramchol.", "size": 1, "hash": "5e97fcbe6bc42c804f24925d839ffb99", "id": 9}, {"samples": [{"hash": "lb6ke9H3JoN", "uri": "/contracts/lb6ke9H3JoN#analysis-sets", "label": "Investigator Agreement", "score": 29.5480929874, "published": true}], "snippet_links": [{"key": "safety-and", "type": "clause", "offset": [27, 37]}, {"key": "effectiveness-analyses", "type": "clause", "offset": [38, 60]}, {"key": "safety-analysis-set", "type": "clause", "offset": [122, 141]}, {"key": "test-article", "type": "definition", "offset": [201, 213]}, {"key": "case-analysis", "type": "definition", "offset": [369, 382]}, {"key": "at-any-time", "type": "clause", "offset": [526, 537]}], "snippet": "Analysis datasets used for safety and effectiveness analyses of this study are defined as follows. The treatment-emergent safety analysis set will include all eyes with attempted implantation with the test article (successful or aborted after contact with the eye). All-Implanted Analysis Set (AAS) will include all eyes with successful test article implantation. Best-Case Analysis Set (BAS) will include all eyes with successful test article implantation that had \u30fb at least 1 postoperative visit; \u30fb no macular degeneration at any time; and \u30fb no major protocol violation", "size": 1, "hash": "b8151e1cc644abea91377278740a1ee8", "id": 10}], "next_curs": "ClYSUGoVc35sYXdpbnNpZGVyY29udHJhY3RzcjILEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhZhbmFseXNpcy1zZXRzIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"title": "Analysis Sets", "children": [["safety-analysis-set", "Safety Analysis Set"], ["full-analysis-set", "Full Analysis Set"], ["per-protocol-analysis-set", "Per Protocol Analysis Set"], ["intent-to-treat", "Intent-to-Treat"], ["", ""]], "parents": [["pregnancy-in-the-clinical-study", "Pregnancy in the Clinical Study"], ["physical-examinations", "Physical Examinations"], ["special-situations", "Special Situations"], ["responsibilities-of-the-sponsor", "Responsibilities of the Sponsor"], ["retention-of-study-documents", "Retention of Study Documents"]], "size": 20, "id": "analysis-sets", "related": [["analysis", "Analysis", "Analysis"], ["investment-analysis-and-implementation", "Investment Analysis and Implementation", "Investment Analysis and Implementation"], ["analysis-and-monitoring", "ANALYSIS AND MONITORING", "ANALYSIS AND MONITORING"], ["statistical-sampling-documentation", "Statistical Sampling Documentation", "Statistical Sampling Documentation"], ["fundamental-analysis", "Fundamental Analysis", "Fundamental Analysis"]], "related_snippets": [], "updated": "2025-07-07T12:37:53+00:00", "also_ask": [], "drafting_tip": "", "explanation": "The 'Analysis Sets' clause defines the specific groups of data or subjects that will be included in various analyses within a study or project. Typically, this clause outlines criteria for inclusion in different sets, such as intent-to-treat, per-protocol, or safety populations, and may specify how subjects are assigned to each set based on their participation or data completeness. By clearly delineating which data are analyzed in each context, the clause ensures consistency, transparency, and reproducibility in the interpretation of study results."}, "json": true, "cursor": ""}}