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{"after": {"end": 886, "start": 0, "text": "L’efficacité de l’eltrombopag oral chez les patients pédiatriques âgés de 2 à 17 ans atteints d’AMS réfractaire/récidivante (cohorte A, n=14) ou naïve de traitement (cohorte B, n=37) a été évaluée dans une étude, en ouvert, non contrôlée, à escalade de dose intra-patient (N=51 au total) (étude CETB115E2201) (voir également rubrique 4.2). La cohorte A était composée de 14 patients atteints d’AMS réfractaire (6 patients) ou récidivante (8 patients). Ces 14 patients ont reçu l’un des deux traitements suivants : 1) eltrombopag plus globuline équine anti-thymocyte (eATG)/ciclosporine A (CsA) ou 2) eltrombopag plus CsA. Dans la cohorte B, 37 patients AMS naïfs de TIS ont été traités avec eATG et CsA en plus de l’eltrombopag. La durée du traitement était de 26 semaines avec une période de suivi supplémentaire de 52 semaines et un suivi à long terme pouvant aller jusqu’à trois ans.", "truncated": false}, "after_length": 886, "after_sha256": "c90a2641da63cfd34116ee3ffad93535889141ac0029f08429f65d2d48a08b03", "annex": "I", "before": {"end": 836, "start": 0, "text": "L’efficacité de l’eltrombopag oral chez les patients pédiatriques âgés de 2 à 17 ans atteints d’AMS réfractaire/récidivante (cohorte A, n=14) ou naïve de traitement (cohorte B, n=37) est évaluée dans une étude en cours, en ouvert, non contrôlée, à escalade de dose intra-patient (N=51 au total) (étude CETB115E2201) (voir également rubrique 4.2). La cohorte A était composée de 14 patients atteints d’AMS réfractaire (6 patients) ou récidivante (8 patients). Ces 14 patients ont reçu l’un des deux traitements suivants : 1) eltrombopag plus globuline équine anti-thymocyte (eATG)/ciclosporine A (CsA) ou 2) eltrombopag plus CsA. Dans la cohorte B, 37 patients AMS naïfs de TIS ont été traités avec eATG et CsA en plus de l’eltrombopag. La durée du traitement était de 26 semaines avec une période de suivi supplémentaire de 52 semaines.", "truncated": false}, "before_length": 836, "before_sha256": "bc3bcdc2da9b76609fdba2a218f5cb78908fb5da10d4816dfd3cb1ea71295346", "change_kind": "content", "change_operations": [{"after_end": 186, "after_start": 183, "before_end": 185, "before_start": 183, "kind": "replace"}, {"after_end": 188, "after_start": 187, "before_end": 186, "before_start": 186, "kind": "insert"}, {"after_end": 211, "after_start": 211, "before_end": 218, "before_start": 209, "kind": "delete"}, {"after_end": 884, "after_start": 827, "before_end": 834, "before_start": 834, "kind": "insert"}], "classification_method": "documentary_rules_v2", "clinical_candidate": true, "comparison_basis": "word_tracked_revisions", "derivation_provider": "Medyx", "display_covers_all_edits": true, "edit_alignment_method": "string_sequence_alignment_trimmed_v2", "edit_counts": {"chars_deleted": 11, "chars_inserted": 61}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-70df122f3fe6ecfc41f7821f", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/001110", "medicine_name": "Revolade", "medicine_slug": "revolade", "observed_at": "2026-10-12T19:00:59Z", "pipeline_version": "2.0.0", "presentation_label": "Revolade 12,5 mg, comprimés pelliculés Revolade 25 mg, comprimés pelliculés Revolade 50 mg, comprimés pelliculés Revolade 75 mg, comprimés pelliculés", "presentation_occurrence": 1, "presentation_status": "heading_extracted_unverified", "review": {"label": null, "medical_relevance": null, "reviewed_at": null, "reviewer_id": null, "state": "pending"}, "section_code": "5.1", "section_type": "pharmacology", "source_provider": "European Medicines Agency", "source_sha256": "beb4f19a3e0f616ed443c376a57c0d045cc0d750999f91d3b3f42e67268b1226", "source_snapshot_id": "source-b92342d26cc66c69fd923acf", "source_updated_at": "2026-02-26", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/revolade-epar-product-information-tracked-changes_fr.docx", "text_normalization": "Tabs, line breaks and whitespace runs become one space; outer whitespace is trimmed.", "word_paragraph_index": 1197}
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