Survey Invitation: Ivonescimab Real-World Safety Profile
This survey's main focus is to determine if there are notable differences between the safety profile of the HARMONI studies and observations from real-world clinical practice.
1. 此表單將記錄你的姓名,請(qǐng)?zhí)顚懺撔畔ⅰ?/legend>
2. Respondent's Hospital Name 您的醫(yī)院名稱?
3. What is your professional title? 您的職稱是什么?
Resident Physician (住院醫(yī)師) Attending Physician (主治醫(yī)師) Associate Chief Physician (副主任醫(yī)師) Chief Physician (主任醫(yī)師)
4. What is your primary professional role? 您的主要專業(yè)是什么?
Medical Oncologist-腫瘤內(nèi)科 Pulmonologist / Respiratory Physician-呼吸科 Radiation Oncologist- 放療科 Thoracic Surgeon- 胸外科 其他
5. Have you participated in the HARMONi series of clinical trials? (Select all that apply) 您是否參與過HARMONi系列臨床研究?(可多選)
HARMONi-A trial HARMONi-2 trial HARMONi-6 trial HARMONi-7 trial 其他
6. Do you have real-world practice experience using Ivonescimab (outside of a clinical trial)?您在真實(shí)世界中有使用Ivonescimab的經(jīng)驗(yàn)嗎?
Yes No
7. On a scale of 1 to 5, how would you rate the overall manageability of Ivonescimab's safety profile in your patients? (1 = Very easy, 5 = Very difficult ) 從1到5分,您如何評(píng)價(jià)Ivonescimab在您患者中的總體安全性管理難度?( 1 = 非常容易管理, 5 = 非常難以管理)
8. In your experience, how well does the real-world safety profile of Ivonescimab align with the safety data reported in its pivotal clinical trials?根據(jù)您的經(jīng)驗(yàn),Ivonescimab的真實(shí)世界安全性特征與在其關(guān)鍵性臨床研究中報(bào)告的患者安全性數(shù)據(jù)符合程度如何?
Very well; the real-world profile is nearly identical to the trial data. - 非常符合;真實(shí)世界情況與研究數(shù)據(jù)幾乎完全相同 Generally well; there are minor differences but no major surprises. -基本符合;存在細(xì)微差異,但無重大意外 Moderately well; I have observed some notable differences in the frequency or severity of certain AEs. -中等程度符合;我觀察到在某些不良事件的發(fā)生率或嚴(yán)重程度上存在一些顯著差異 Poorly; the real-world safety profile is significantly different from what was reported.- 符合度差;真實(shí)世界安全性特征與研究報(bào)告有顯著不同
9. If you noted any differences in the question above, please describe what has surprised you or differed most in your real-world experience compared to the trial data. (higher/lower rates of a specific AE, unexpected toxicities, better/worse than expected patient tolerability, e.g., in real world we observed higher/lower bleeding rate in sq-NSCLC) 如果您在上一題中觀察到任何差異,請(qǐng)描述在您的真實(shí)世界經(jīng)驗(yàn)中,哪些方面最令您意外或差異最大?** (例如在真實(shí)世界中我們觀察到鱗狀非小細(xì)胞肺癌患者的出血率更高/更低, 或者其他 特定不良事件的發(fā)生率更高/更低,非預(yù)期的毒性反應(yīng),患者耐受性好于/差于預(yù)期)
10. How does the overall safety profile of Ivonescimab compare to a combination of a PD-1/L1 inhibitor + a VEGF inhibitor (e.g., atezolizumab + bevacizumab, Benmelstobart + anlotinib)?與PD-1/L1+VEGF的聯(lián)合治療方案相比(如:阿替利珠單抗+貝伐珠單抗/貝莫蘇拜單抗+安羅替尼),Ivonescimab的總體安全性特征如何?
Significantly more challenging- 挑戰(zhàn)性顯著更高 Moderately more challenging- 挑戰(zhàn)性中等程度更高 Similar in challenge- 挑戰(zhàn)性相似 Moderately less challenging- 挑戰(zhàn)性中等程度更低 Significantly less challenging- 挑戰(zhàn)性顯著更低
11. If you noted any differences in the question above, please describe what has surprised you or differed most compared to a combination of a PD-1/L1 inhibitor + a VEGF inhibitor. (e.g., higher/lower rates of a specific AE, unexpected toxicities, difficult to manage)如果您在上一題中觀察到任何差異,請(qǐng)描述與PD-1/L1抑制劑聯(lián)合VEGF抑制劑方案相比,哪些方面最令您意外或差異最大? (例如,特定不良事件的發(fā)生率更高/更低,非預(yù)期的毒性反應(yīng),更難以管理等)
12. Compared to managing AEs for an IO monotherapy , how often do you need to take the following actions for patients on Ivonescimab? *與管理IO單藥治療 的不良事件相比,您為使用Ivonescimab的患者采取以下措施的頻率如何?
Permanent Discontinuation-永久停藥
13. Compared to managing AEs for an IO + VEGF combination, how often do you need to take the following actions for patients on Ivonescimab?與管理IO聯(lián)合VEGF抑制劑方案的不良事件相比,您為使用Ivonescimab的患者采取以下措施的頻率如何?
Permanent Discontinuation-永久停藥
14. Please describe any unique challenges or successful strategies you have developed for managing AEs associated with Ivonescimab.請(qǐng)描述您在管理Ivonescimab相關(guān)不良事件時(shí)遇到的任何獨(dú)特挑戰(zhàn)或成功策略(例如,關(guān)于特定不良事件的監(jiān)測(cè)、患者教育,或如何處理同時(shí)出現(xiàn)的毒性反應(yīng)等方面)
15. In your clinical judgment, how does the impact on patient quality of life (QoL) from Ivonescimab's side effects compare to IO monotherapy? 根據(jù)您的臨床判斷,與IO單藥治療相比,Ivonescimab的副作用對(duì)患者生活質(zhì)量(QoL)的影響如何?
Worse impact on QoL- 對(duì)QoL影響更差 Similar impact on QoL- 對(duì)QoL影響相似 Better impact on QoL- 對(duì)QoL影響更好
16. How does the impact on patient QoL from Ivonescimab's side effects compare to an IO + VEGF combination? 與IO聯(lián)合VEGF抑制劑方案相比,Ivonescimab的副作用對(duì)患者生活質(zhì)量(QoL)的影響如何?
Worse impact on QoL- 對(duì)QoL影響更差 Similar impact on QoL- 對(duì)QoL影響相似 Better impact on QoL- 對(duì)QoL影響更好
17. [Optional] What is the most common feedback (positive or negative) you receive from patients regarding the safety and tolerability of Ivonescimab?【可選】關(guān)于Ivonescimab的安全性和耐受性問題,您從患者那里收到的最常見的反饋(無論是正面的還是負(fù)面的)是什么?
18. [Optional]Do you have any additional comments, insights, or concerns regarding the use of Ivonescimab in real-world clinical practice that were not covered in this survey?【可選】對(duì)于在真實(shí)世界臨床實(shí)踐中使用Ivonescimab,您是否有任何本問卷未涵蓋的額外評(píng)論、見解或顧慮?
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