Oncostat / grstat

Statistical package for clinical research in GR
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Améliorer les butterfly plots #20

Open DanChaltiel opened 1 month ago

DanChaltiel commented 1 month ago

Fig 3. Adverse events. The panel on the left is a butterfly plot showing the proportion of patients experiencing an adverse event, whatever the grade (light red for the busulfan and melphalan [BuMel] arm and light blue for the vincristine, dactinomycin, and ifosfamide [VAI] plus whole-lung irradiation [WLI] arm) and a severe adverse event (dark red for the BuMel arm and dark blue for VAI plus WLI arm) according to the randomization group. The panel on the right displays the relative risk of a severe adverse event in patients with BuMel relative to patients with VAI plus WLI, with 95% CIs for a 2 × 2 table. The acute toxicity related to chemotherapy was assessed after each course, using a list of 22 selected items from the National Cancer Institute Common Terminology Criteria for Adverse Events (version 2.0). A modified list of items was used to evaluate toxicity after radiotherapy, using Radiation Therapy Oncology Group classification for eight types of specific toxicities. A free text area was available to document other adverse reactions. The toxicity items were then pooled by category: bladder toxicity, cardiac toxicity, GI toxicity, general deterioration, hematologic toxicity, infection, liver toxicity, lung toxicity, neurologic toxicity (including mood alteration), renal toxicity, and skin toxicity. The respiratory tract toxicity (larynx, pharynx, salivary gland) reported after radiotherapy was pooled within the category of GI toxicity because of small numbers and because they were usually associated. Details are provided in the Data Supplement. For each adverse event type, the analysis was based on the maximum grade observed over the whole maintenance treatment duration. A grade 4 hematologic toxicity and a grade 3 or higher nonhematologic toxicity were classified as severe toxicities. The categories of adverse events was ordered by decreasing value of the relative risk of severe toxicity. This analysis was performed on the safety set (127 patients taking VAI plus WLI and 117 patients taking BuMel), excluding patients who did not receive the treatment allocated by randomization (as-treated population), as well as patients with missing data for toxicity assessment. The number of chemotherapy courses followed by toxicity over the whole maintenance treatment duration is detailed in the Data Supplement.