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{"after": {"end": 795, "start": 0, "text": "L'induction par R-CHOP (rituximab 375 mg/m2 au Jour 0 ou 1, cyclophosphamide 750 mg/m2 au Jour 1, doxorubicine 50 mg/m2 au Jour 1, vincristine 1,4 mg/m2 jusqu'à un maximum de 2 mg au Jour 1, et prednisone 100 mg aux Jours 1 à 5) en alternance avec R-DHAP (rituximab 375 mg/m2 au Jour 0 ou 1, dexaméthasone 40 mg les Jours 1 à 4, Ara-C 2x 2 g/m2 toutes les 12 heures le Jour 2, cisplatine 100 mg/m2 (alternativement oxaliplatine 130 mg/m²) le Jour 1, et G-CSF 5 µg/kg à partir du Jour 6 jusqu’à la récupération du nombre de globules blancs) était identique pour les 3 bras de traitement. Le traitement d’entretien par rituximab était autorisé dans tous les groupes de traitement (59,7 % dans le bras IMBRUVICA ; 62,5 % dans le bras AGCS) conformément aux recommandations nationales de traitement.", "truncated": false}, "after_length": 795, "after_sha256": "e80853ea75db21b23a8bbd637d0205b0d78c9f11fe99ec20cc1da970a81eb3e7", "annex": "I", "before": {"end": 733, "start": 0, "text": "L'induction par R-CHOP (rituximab 375 mg/m2 au Jour 0 ou 1, cyclophosphamide 750 mg/m2 au Jour 1, doxorubicine 50 mg/m2 au Jour 1, vincristine 1,4 mg/m2 jusqu'à un maximum de 2 mg au Jour 1, et prednisone 100 mg aux Jours 1 à 5) en alternance avec R-DHAP (rituximab 375 mg/m2 au Jour 0 ou 1, dexaméthasone 40 mg les Jours 1 à 4, Ara-C 2x 2 g/m2 toutes les 12 heures le Jour 2, cisplatine 100 mg/m2 (alternativement oxaliplatine 130 mg/m²) le Jour 1, et G-CSF 5 µg/kg le Jour 6) était identique pour les 3 bras de traitement. Le traitement d’entretien par rituximab était autorisé dans tous les groupes de traitement (59,7 % dans le bras IMBRUVICA ; 62,5 % dans le bras AGCS) conformément aux recommandations nationales de traitement.", "truncated": false}, "before_length": 733, "before_sha256": "1f6046cb21ae7e2663f67e6c37f507da5639c90f4342ad497dc5824b0184dc70", "change_kind": "content", "change_operations": [{"after_end": 478, "after_start": 467, "before_end": 469, "before_start": 467, "kind": "replace"}, {"after_end": 538, "after_start": 485, "before_end": 476, "before_start": 476, "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": 2, "chars_inserted": 64}, "extraction_scope": "word/document.xml paragraphs, including table paragraphs", "id": "change-5d539a76dc54b7ca27f736dd", "language": "fr", "medical_validation": false, "medicine_id": "EMEA/H/C/003791", "medicine_name": "Imbruvica", "medicine_slug": "imbruvica", "observed_at": "2026-10-12T19:04:40Z", "pipeline_version": "2.0.0", "presentation_label": "IMBRUVICA 140 mg gélules", "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": "4b0b32ce32024a965e4ce48fb2cbdea69dafe9803472bdd5e64e2c6b939c8445", "source_snapshot_id": "source-2f9ae65220663d4e0dbb5c63", "source_updated_at": "2025-10-27", "source_url": "https://www.ema.europa.eu/fr/documents/product-information-tracked-changes/imbruvica-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": 957}
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