A randomised double blind placebo controlled trial of infusional subcutaneous octreotide in the management of malignant bowel obstruction in people with advanced cancer.

Data set includes individual participant data for 112 consenting participants. The dataset includes CSV files for: the number of days free of vomiting as reported by patients daily, measured 72 hours after the first administration of study medication; Patient-rated Global Impression of Change; the number of patient-reported episodes of vomiting; survival as date of death; nausea and Pain scores using NCI CTCAE criteria and Brief Pain Inventory; functional status (Australian modified Karnofsky Performance Scale (AKPS); and; protocol defined “as needed” symptom control medications (hyoscine butylbromide for colicky pain, morphine for pain, haloperidol for nausea). Quality of Life measures used the EORTC C15, Facit Pal and caregiver Quality of life was measured using the Caregiver Quality of Life Index. Data is available for screening, baseline, each day of intervention and 4 weeks of follow-up. Health Service Utilisation data was collected for up to 4 weeks post intervention.

本数据集包含112名签署知情同意书的受试者的个体受试者数据，涵盖以下类型的CSV文件：受试者每日报告的无呕吐天数（评估节点为首次服用研究药物后72小时）、受试者自评总体变化印象量表（Patient-rated Global Impression of Change）、受试者报告的呕吐发作次数、以死亡日期记录的生存数据、采用美国国家癌症研究所常见不良反应事件评价标准（NCI CTCAE）及简明疼痛量表（Brief Pain Inventory）评定的恶心与疼痛评分、功能状态（澳大利亚改良卡诺夫斯基绩效量表，Australian modified Karnofsky Performance Scale, AKPS），以及方案规定的"as needed"症状控制药物数据：丁溴东莨菪碱用于绞痛镇痛、吗啡用于疼痛控制、氟哌啶醇用于恶心干预。生活质量评估采用欧洲癌症研究与治疗组织C15量表（EORTC C15）、Facit Pal量表；照顾者生活质量则通过照顾者生活质量指数（Caregiver Quality of Life Index）评定。数据覆盖筛查期、基线期、干预期每日及4周随访期的全部观测指标，干预后最长4周内同步收集了医疗服务利用相关数据。