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Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system [4–7]. The PRO-CTCAE item library contains 124 items reflecting 78 symptomatic adverse events drawn from the CTCAE version 4.0. The PRO-CTCAE was developed to be used in conjunction with the CTCAE [7]. PRO-CTCAE symptom attri-

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Impact of Change From CTCAE Version 3 to CTCAE Version 4

ReferencesTrotti, A., Colevas, A. D., Setser, A., Rusch, V., Jaques, D., Budach, V., et al. (2003). CTCAE v3.0: Development of a comprehensive grading system for the adverse events of cancer treatment. Seminars in Radiation Oncology, 13, 176–181.Article PubMed Google Scholar National Cancer Institute, National Institutes of Health, US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Published May 28, 2009; Revised version 4.03 June 14, 2010 (Vol. Available from: Accessed 20 May 2013).Basch, E. (2010). The missing voice of patients in drug-safety reporting. New England Journal of Medicine, 362(10), 865–869. doi:10.1056/NEJMp0911494.Article CAS PubMed Central PubMed Google Scholar Basch, E., Iasonos, A., McDonough, T., Barz, A., Culkin, A., Kris, M. G., et al. (2006). Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: Results of a questionnaire-based study. Lancet Oncology, 7, 903–909. doi:10.1016/S1470-2045(06)70910-X.Article PubMed Google Scholar Basch, E., Jia, X., Heller, G., Barz, A., Sit, L., Fruscione, M., et al. (2009). Adverse symptom event reporting by patients versus clinicians: Relationships with clinical outcomes. Journal of the National Cancer Institute, 101(23), 1624–1632. doi:10.1093/jnci/djp386.Article PubMed Google Scholar Atkinson, T. M., Li, Y., Coffey, C. W., Sit, L., Shaw, M., Lavene, D., et al. (2012). Reliability of adverse symptom event reporting by clinicians. Quality of Life Research, 21(7), 1159–1164. doi:10.1007/s11136-011-0031-4.Article PubMed Central PubMed Google Scholar Xiao, C., Polomano, R., & Bruner, D. W. (2012). Comparison between patient-reported and clinician-observed symptoms in oncology. Cancer Nursing,. doi:10.1097/NCC.0b013e318269040f. Google Scholar Greimel, E. R., Bjelic-Radisic, V., Pfisterer, J., Hilpert, F., Daghofer, F., Pujade-Lauraine, E., et al. (2011). Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials. Supportive Care in Cancer, 19(9), 1421–1427. doi:10.1007/s00520-010-0969-8.Article PubMed Google Scholar Flores, L. T., Bennett, A. V., Law, E. B., Hajj, C., Griffith, M. P., & Goodman, K. A. (2012). Patient-reported outcomes versus clinician symptom reporting during chemoradiation for rectal cancer. Gastrointestinal Cancer Research, 5(4), 119–124.PubMed Google Scholar Basch, E., Iasonos, A., Barz, A., Culkin, A., Kris, M. G., Artz, D., et al. (2007). Long-term toxicity monitoring via electronic patient-reported outcomes in patients. Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system [4–7]. The PRO-CTCAE item library contains 124 items reflecting 78 symptomatic adverse events drawn from the CTCAE version 4.0. The PRO-CTCAE was developed to be used in conjunction with the CTCAE [7]. PRO-CTCAE symptom attri- Adverse Events (CTCAE) Version 4 U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES CTCAE 4 - Aug : Blood and lymphatic system disorders 3 2. Blood and CTCAE Version 4 Alice Chen, MD, FACP Investigational Drug Branch, CTEP, DCTD National Cancer Institute. CTCAE v3.0 Issues MedDRA CTCAE v3.0 Terms Multiple CTCAE version 4 terms are identical to corresponding Preferred Terms from the Medical Dictionary for Regulatory Affairs (MedDRA), based on a harmonization process that occurred during the update from CTCAE version 3 to version 4. Multiregional contexts (pp. 177–190). Hoboken, NJ: John Wiley & Sons. Google Scholar Tourangeau, R. (1984). Cognitive science and survey methods. In T. Jabine, M. Straf, J. Tanur, & R. Tourangeau (Eds.), Cognitive aspects of survey design: Building a bridge between disciplines (pp. 73–100). Washington, DC: National Academy Press. Google Scholar Namey, E., Guest, G., Thairy, L., & Johnson, L. (2008). Data reduction techniques for large qualitative data sets. In G. Guest & K. M. MacQueen (Eds.), Handbook for team-based qualitative research (pp. 137–161). Lanham, MD: AltaMira Press. Google Scholar Saldana, J. (2009). The coding manual for qualitative researchers. Los Angeles, CA: Sage Publications. Google Scholar Basch, E. (2012). Beyond the FDA PRO guidance: Steps toward integrating meaningful patient-reported outcomes into regulatory trials and US drug labels. Value in Health, 15(3), 401–403. doi:10.1016/j.jval.2012.03.1385.Article PubMed Google Scholar Symptom Management and Quality of Life Steering Committee. Clinical trials planning meeting—building bridges: The identification of core symptoms and health-related quality of life domains for use in cancer research (September 22–23, 2011. Available from: Accessed 7 June 2012).Mitchell, S. A., Lang, K., Nichols, C., Clauser, S. B., Federico, V., Lalla, D., et al. (2012). Validation of the NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in women receiving treatment for metastatic breast cancer. Chicago, IL: Annual Meeting of the American Society of Clinical Oncology. Google Scholar Dueck, A. C., Mendoza, T., Mitchell, S. A., Reeve, B. B., Castro, K., Denicoff, A., et al. (2012). Validity and reliability of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Chicago, IL: Annual Meeting of the American Society of Clinical Oncology. Google Scholar Coons, S. J., Gwaltney, C. J., Hays, R. D., Lundy, J. J., Sloan, J. A., Revicki, D. A., et al. (2009). Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO good research practices task force report. Value in Health, 12(4), 419–429. doi:10.1111/j.1524-4733.2008.00470.x.Article PubMed Google Scholar (2012) Methodological standards and patient-centeredness in comparative effectiveness research—The PCORI perspective. JAMA, 307(15), 1636–1640. doi:10.1001/jama.2012.466.Download references

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ReferencesTrotti, A., Colevas, A. D., Setser, A., Rusch, V., Jaques, D., Budach, V., et al. (2003). CTCAE v3.0: Development of a comprehensive grading system for the adverse events of cancer treatment. Seminars in Radiation Oncology, 13, 176–181.Article PubMed Google Scholar National Cancer Institute, National Institutes of Health, US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Published May 28, 2009; Revised version 4.03 June 14, 2010 (Vol. Available from: Accessed 20 May 2013).Basch, E. (2010). The missing voice of patients in drug-safety reporting. New England Journal of Medicine, 362(10), 865–869. doi:10.1056/NEJMp0911494.Article CAS PubMed Central PubMed Google Scholar Basch, E., Iasonos, A., McDonough, T., Barz, A., Culkin, A., Kris, M. G., et al. (2006). Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: Results of a questionnaire-based study. Lancet Oncology, 7, 903–909. doi:10.1016/S1470-2045(06)70910-X.Article PubMed Google Scholar Basch, E., Jia, X., Heller, G., Barz, A., Sit, L., Fruscione, M., et al. (2009). Adverse symptom event reporting by patients versus clinicians: Relationships with clinical outcomes. Journal of the National Cancer Institute, 101(23), 1624–1632. doi:10.1093/jnci/djp386.Article PubMed Google Scholar Atkinson, T. M., Li, Y., Coffey, C. W., Sit, L., Shaw, M., Lavene, D., et al. (2012). Reliability of adverse symptom event reporting by clinicians. Quality of Life Research, 21(7), 1159–1164. doi:10.1007/s11136-011-0031-4.Article PubMed Central PubMed Google Scholar Xiao, C., Polomano, R., & Bruner, D. W. (2012). Comparison between patient-reported and clinician-observed symptoms in oncology. Cancer Nursing,. doi:10.1097/NCC.0b013e318269040f. Google Scholar Greimel, E. R., Bjelic-Radisic, V., Pfisterer, J., Hilpert, F., Daghofer, F., Pujade-Lauraine, E., et al. (2011). Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials. Supportive Care in Cancer, 19(9), 1421–1427. doi:10.1007/s00520-010-0969-8.Article PubMed Google Scholar Flores, L. T., Bennett, A. V., Law, E. B., Hajj, C., Griffith, M. P., & Goodman, K. A. (2012). Patient-reported outcomes versus clinician symptom reporting during chemoradiation for rectal cancer. Gastrointestinal Cancer Research, 5(4), 119–124.PubMed Google Scholar Basch, E., Iasonos, A., Barz, A., Culkin, A., Kris, M. G., Artz, D., et al. (2007). Long-term toxicity monitoring via electronic patient-reported outcomes in patients

2025-04-03
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Multiregional contexts (pp. 177–190). Hoboken, NJ: John Wiley & Sons. Google Scholar Tourangeau, R. (1984). Cognitive science and survey methods. In T. Jabine, M. Straf, J. Tanur, & R. Tourangeau (Eds.), Cognitive aspects of survey design: Building a bridge between disciplines (pp. 73–100). Washington, DC: National Academy Press. Google Scholar Namey, E., Guest, G., Thairy, L., & Johnson, L. (2008). Data reduction techniques for large qualitative data sets. In G. Guest & K. M. MacQueen (Eds.), Handbook for team-based qualitative research (pp. 137–161). Lanham, MD: AltaMira Press. Google Scholar Saldana, J. (2009). The coding manual for qualitative researchers. Los Angeles, CA: Sage Publications. Google Scholar Basch, E. (2012). Beyond the FDA PRO guidance: Steps toward integrating meaningful patient-reported outcomes into regulatory trials and US drug labels. Value in Health, 15(3), 401–403. doi:10.1016/j.jval.2012.03.1385.Article PubMed Google Scholar Symptom Management and Quality of Life Steering Committee. Clinical trials planning meeting—building bridges: The identification of core symptoms and health-related quality of life domains for use in cancer research (September 22–23, 2011. Available from: Accessed 7 June 2012).Mitchell, S. A., Lang, K., Nichols, C., Clauser, S. B., Federico, V., Lalla, D., et al. (2012). Validation of the NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in women receiving treatment for metastatic breast cancer. Chicago, IL: Annual Meeting of the American Society of Clinical Oncology. Google Scholar Dueck, A. C., Mendoza, T., Mitchell, S. A., Reeve, B. B., Castro, K., Denicoff, A., et al. (2012). Validity and reliability of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Chicago, IL: Annual Meeting of the American Society of Clinical Oncology. Google Scholar Coons, S. J., Gwaltney, C. J., Hays, R. D., Lundy, J. J., Sloan, J. A., Revicki, D. A., et al. (2009). Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO good research practices task force report. Value in Health, 12(4), 419–429. doi:10.1111/j.1524-4733.2008.00470.x.Article PubMed Google Scholar (2012) Methodological standards and patient-centeredness in comparative effectiveness research—The PCORI perspective. JAMA, 307(15), 1636–1640. doi:10.1001/jama.2012.466.Download references

2025-04-20
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Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Viewer (English/Japanese) You can search, browse and bookmark CTCAE v4.0 by following languages.・English・Japanese (JCOG Edition)[Including Data]・CTCAE v4.03/MedDRA v12.0 (Japanese description : MedDRA/J v20.1) SEP 12, 2017 revised edition. What’s New May 11, 2022Version 1.8.1 Fix bug.Update to latest SDKs. App Privacy The developer, TAKAFUMI MIZUGUCHI, indicated that the app’s privacy practices may include handling of data as described below. For more information, see the developer’s privacy policy. Data Not Linked to You The following data may be collected but it is not linked to your identity: Usage Data Diagnostics Privacy practices may vary, for example, based on the features you use or your age. Learn More Information Seller TAKAFUMI MIZUGUCHI Size 17.7 MB Category Medical Compatibility iPhone Requires iOS 12.0 or later. iPad Requires iPadOS 12.0 or later. iPod touch Requires iOS 12.0 or later. Mac Requires macOS 11.0 or later and a Mac with Apple M1 chip or later. Apple Vision Requires visionOS 1.0 or later. Languages English, Japanese Age Rating 12+ Infrequent/Mild Medical/Treatment Information Copyright © 2012-2022 Takafumi Mizuguchi Price Free In-App Purchases Remove Ads $3.99 Developer Website App Support Privacy Policy Developer Website App Support Privacy Policy More By This Developer You Might Also Like

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A systematic review. Journal of Clinical Oncology, 24(9), 1459–1473. doi:10.1200/JCO.2005.02.8332.Article PubMed Google Scholar Wild, D., Eremenco, S., Mear, I., Martin, M., Houchin, C., Gawlicki, M., et al. (2009). Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: The ISPOR patient-reported outcomes translation and linguistic validation good research practices task force report. Value in Health, 12(4), 430–440. doi:10.1111/j.1524-4733.2008.00471.x.Article PubMed Google Scholar Basch, E., Reeve, B. B., Mitchell, S. A., Clauser, S. B., Minasian, L. M., Atkinson, T. M., et al. (Under Review). Development of the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Journal of National Cancer Institute.Willis, G. B. (2005). Cognitive interviewing: A tool for improving questionnaire design. Thousand Oaks, CA: SAGE Publications, Inc. Google Scholar Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., et al. (2011). Content validity-establishing and reporting the evidence in newly Developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 2-assessing respondent understanding. Value in Health, 14(8), 978–988. doi:10.1016/j.jval.2011.06.013.Article PubMed Google Scholar Bowen, G. A. (2008). Naturalistic inquiry and the saturation concept: A research note. Qualitative Research, 8(1), 137–152. doi:10.1177/1468794107085301.Article Google Scholar Guest, G., Bunce, A., & Johnson, L. (2006). How many interviews are enough? An experiment with data saturation and variability. Field Methods, 18, 59–82. doi:10.1177/1525822X05279903.Article Google Scholar Jobe, J. B., & Mingay, D. J. (1989). Cognitive research improves questionnaires. American Journal of Public Health, 79(8), 1053–1055.Article CAS PubMed Google Scholar Jobe, J. B. (2003). Cognitive psychology and self-reports: Models and methods. Quality of Life Research, 12(3), 219–227.Article PubMed Google Scholar Miller, K. (2003). Conducting cognitive interviews to understand question-response limitations. American Journal of Health Behavior, 27(Suppl 3), S264–S272.Article PubMed Google Scholar Schwarz, N., Oyserman, D., & Petycheva, E. (2010). Cognition, communication, and culture: Implications for the survey response process. In J. A. Harkness, M. Braun, B. Edwards, T. P. Johnson, L. E. Lyberg, P. P. Mohler, et al. (Eds.), Survey methods in multinational, multicultural, and

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Receiving chemotherapy. Journal of Clinical Oncology, 25(34), 5374–5380. doi:10.1200/JCO.2007.11.2243.Article PubMed Google Scholar Tang, B., Giuliani, M., Le, L. W., Higgins, J., Bezjak, A., Brade, A., et al. (2013). Capturing acute toxicity data during lung radiotherapy by using a patient-reported assessment tool. Clinical Lung Cancer, 14(2), 108–112. doi:10.1016/j.cllc.2012.06.003.Article PubMed Google Scholar US Department of Health and Human Services. Guidance for industry. patient-reported outcome measures: Use in medical development to support labeling claims (December 2009. Available from: Accessed 20 May 2013).European Medicines Agency. Committee for medicinal products for human use (CHMP). Pre-authorisation evaluation of medicines for human use: Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products (January 2006, Available from: Accessed 20 May 2013).Ashley, L., Jones, H., Thomas, J., Forman, D., Newsham, A., Morris, E., et al. (2011). Integrating cancer survivors’ experiences into UK cancer registries: Design and development of the ePOCS system (electronic Patient-reported Outcomes from Cancer Survivors). British Journal of Cancer, 105, S74–S81. doi:10.1038/Bjc.2011.424.Article PubMed Central PubMed Google Scholar Banerjee, A. K., & Ingate, S. (2012). Web-based patient-reported outcomes in drug safety and risk management: Challenges and opportunities? Drug Safety, 35(6), 437–446. doi:10.2165/11632390-000000000-00000.Article PubMed Google Scholar Boers-Doets, C. B., Gelderblom, H., Lacouture, M. E., Epstein, J. B., Nortier, J. W., & Kaptein, A. A. (2013). Experiences with the FACT-EGFRI-18 instrument in EGFRI-associated mucocutaneous adverse events. Supportive Care in Cancer,. doi:10.1007/s00520-013-1752-4. Google Scholar Chan, A., & Tan, E. H. (2011). How well does the MESTT correlate with CTCAE scale for the grading of dermatological toxicities associated with oral tyrosine kinase inhibitors? Supportive Care in Cancer, 19(10), 1667–1674. doi:10.1007/s00520-010-0999-2.Article PubMed Google Scholar Farnell, D. J., Mandall, P., Anandadas, C., Routledge, J., Burns, M. P., Logue, J. P., et al. (2010). Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy. Radiotherapy and Oncology, 97(1), 136–142. doi:10.1016/j.radonc.2010.05.011.Article PubMed Google Scholar Quinten, C., Maringwa, J., Gotay, C. C., Martinelli, F., Coens, C., Reeve, B. B., et al. (2011). Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. Journal of the National Cancer Institute, 103(24),

2025-03-30
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Panic Room (2002) 720p - BDRip - x264 - [Hindi + Tamil + Eng] - 1.1GB - ESub - MovCr GeneralUnique ID : 253102123105059045634899456599623169547 (0xBE69B21F22E28F707D9623CFBA33760B)Complete name : D:HDFRAEN1134[MovCr.com] - Panic Room (2002) 720p - BDRip - x264 - [Hindi + Tamil + Eng] - 1.1GB - ESub - MovCr.mkvFormat : MatroskaFormat version : Version 4 / Version 2File size : 1.14 GiBDuration : 1 h 51 minOverall bit rate : 1 459 kb/sMovie name : www.MovCr.comEncoded date : UTC 2018-08-23 13:18:17Writing application : mkvmerge v25.0.0 ('Prog Noir') 64-bitWriting library : libebml v1.3.6 + libmatroska v1.4.9VideoID : 1Format : AVCFormat/Info : Advanced Video CodecFormat profile : [email protected] Format settings : CABAC / 4 Ref FramesFormat settings, CABAC : YesFormat settings, ReFrames : 4 framesCodec ID : V_MPEG4/ISO/AVCDuration : 1 h 51 minBit rate : 1 050 kb/sWidth : 1 280 pixelsHeight : 534 pixelsDisplay aspect ratio : 2.40:1Original display aspect rat : 2.40:1Frame rate mode : ConstantFrame rate : 23.976 (24000/1001) FPSColor space : YUVChroma subsampling : 4:2:0Bit depth : 8 bitsScan type : ProgressiveBits/(Pixel*Frame) : 0.064Stream size : 840 MiB (72%)Title : www.MovCr.comWriting library : x264 core 152Encoding settings : cabac=1 / ref=4 / deblock=1:-1:-1 / analyse=0x3:0x133 / me=umh / subme=9 / psy=1 / psy_rd=1.00:0.15 / mixed_ref=1 / me_range=24 / chroma_me=1 / trellis=2 / 8x8dct=1 / cqm=0 / deadzone=21,11 / fast_pskip=0 / chroma_qp_offset=-3 / threads=12 / lookahead_threads=1 / sliced_threads=0 / nr=0 / decimate=1 / interlaced=0 / bluray_compat=0 / constrained_intra=0 / bframes=3 / b_pyramid=2 / b_adapt=2 / b_bias=0 / direct=3 / weightb=1 / open_gop=0 / weightp=2 / keyint=250 / keyint_min=23 / scenecut=40 / intra_refresh=0 / rc_lookahead=60 / rc=2pass / mbtree=1 / bitrate=1050 / ratetol=1.0 / qcomp=0.60 / qpmin=0 / qpmax=69 / qpstep=4 / cplxblur=20.0 / qblur=0.5 / vbv_maxrate=31250 / vbv_bufsize=31250 / nal_hrd=none / filler=0 / ip_ratio=1.40 / aq=1:1.00Language : EnglishDefault : YesForced : YesAudio #1ID : 2Format : MPEG AudioFormat version : Version 1Format profile : Layer 3Format settings : Joint stereo / MS StereoCodec ID : A_MPEG/L3Codec ID/Hint : MP3Duration : 1 h 51 minBit rate mode : ConstantBit rate : 128 kb/sChannel(s) : 2 channelsSampling rate : 48.0

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