What Happened to All the Patients? Event Charts for Summarizing Individual Patient Data and Displaying Clinically Significant Changes in Quality of Life Data

Drug Information Journal

Volumn 37, Issue 1, 2003, Pages 11-21

  Atherton, Pamela J ^a   Jasperson, Britta ^a   Nibbe, Andrea ^a   Clement Brown, Kate A ^a   Allmer, Cristine ^a   Novotny, Paul ^a   Erlichman, Charles ^a   Sloan, Jeff A ^a  

^a MAYO CLINIC   (United States)

Author keywords

Clinical trials; Event chart; Oncology; Phase 1 studies; Quality of life

Indexed keywords

2 (2 DIMETHYLAMINOETHYL) 9 METHOXY 5 NITROPYRAZOLO[3,4,5 KL]ACRIDINE; 5 ETHYNYLURACIL; CARBOPLATIN; FLUOROURACIL; IRINOTECAN;

ARTICLE; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CANCER PATIENT; CLINICAL TRIAL; DATA ANALYSIS; HIGH RISK PATIENT; HUMAN; KAPLAN MEIER METHOD; METHODOLOGY; NEUTROPENIA; PATIENT INFORMATION; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; TECHNIQUE;

EID: 0142184291     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150303700104     Document Type: Article

References (24)

1. Francis B, Fuller M. Visualisation of event histories. J Roy Stat Soc. 1996; Series A, 159:301-308.
2. Chuang-Stein C. Statistics for safety data. Chapter 9 in Detection of New Adverse Drug Reactions. 4th ed. London, UK: Macmillan Publisher; 1998.
3. Chuang-Stein C, Le V, Chen W. Recent advances in the analysis and presentation of safety data. Drug Inf J. 2001;35:377-397
4. Goldman AI. Event charts: visualizing survival and other time-events data. Am Stat. 1992;46:13-18.
5. Enas GG. Some useful pictures and methods in survival analysis of oncology data. Proceedings of the Biopharmaceutical Section. Alexandria, VA: American Statistical Association; 1987.
6. Dublin S, Rosenberg PS, Goedert JJ. Patterns and predictors of high-risk sexual behavior in female partners of HIV-infected men with hemophilia. AIDS. 1992;6(5):475-482.
7. Therber A, Delucchi K. Letter to the editor: Comments on 'Event charts: visualizing survival and other timed-events data' by A.I. Goldman. Am Stat. 1992;46:334-335.
8. Lesser ML, Kohn NE, Napolitano BA, Pahwa S. The FU-PLOT: a graphical method for visualizing the timing follow-up in longitudinal studies. Am Stat. 1995;49:139-143.
9. Lee JJ, Hess KR, Dubin JA. Statistical computing and graphics: extensions and applications of event charts. Am Stat. 2000;54(1):63-70.
10. Szarfman A, Talarico L, Levine JG. Analysis and risk assessment of hematological data from clinical trials. In: toxicology of the hematopoietic system. In: Sipes IG, McQueen CA, Gandolfi AJ. Comprehensive Toxicology. Vol 4. New York, NY: Elsevier Science Inc; 1997:365-379.
11. Levine JG, Szarfman A. Standardised data structures and visualisation tools: A way to accelerate the regulatory review of the integrated summary of safety of new drug applications. Biopharma Rep. 1996;4(3):12-17.
12. Szarfman A. Discussion: a report on the activities of the adverse events working groups: focus on improving the detection of rare but serious events. Proceedings of the Biopharmaceutical Section. Alexandria (VA): American Statistical Association; 1999:12-14.
13. 66 Federal Register 63712/Vol. 66, No. 237/Monday, December 10, 2001/Patient Profile Viewer; Notice of Pilot Project.
14. Reid J, Buckner JC, Novotny P, Wright K, Kimmel DW, Schaaf L, Miller L, Wiesenfeld M, Pfeifle DM, Hatfield A. Pharmacokinetics of Irinotecan (CPT-11) in recurrent glioma patients: Results of an NCCTG phase II trial. Proc Am Soc Clin Oncol. 1999;18:141(A540).
15. Cella DF, Tulsky DS, Gray G, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol. 1996;11:570-579.
16. Sloan JA, Loprinzi C, Kuross SA, et al. Randomized comparison of four tools measuring overall quality of life in patients with advanced cancer. J Clin Oncol. 1998;16:3662-3673.
17. Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality of life scores. J Clin Oncol. 1998;16(1):139-144.
18. Jaeschke R, Singer J, Guyatt G. Measurement of health status: Ascertaining the meaning of a change in quality-of-life questionnaire score. Control Clin Trials. 1989;10:407-415.
19. Cella DF, Tulsky DS, Gray G, Sarafian B, Lloyd S, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, Eckberg K, Purl S, Blendowski C, Goodman M, Barnicle M, Stewart I, McHale M, Bonomi P, Kaplan E, Taylor S, Thomas C, Harris J. The Functional Assessment of Cancer Therapy (FACT) scale: Development and validation of the general measure. J Clin Oncol. 1993;11(3):570-579.
20. Colon-Otero G, Krook JE, Sloan JA, Windschitl HE, Niedringhaus RD, Al-Khatib HS, Hauge MD, Marks RS, Geyer S, Hillman S, Knowlton L, Jett J. A phase II trial of edatrexate, vinblastine, adriamycin, cisplatin and filgrastim (EVAC/G-CSF) in patients with advanced non-small cell carcinoma of the lungs: a north central cancer center treatment group trial. Am J Clin Oncol. 2002;26(6):551-555.
21. Kugler JW, Hobday TJ, Mahoney MM, Sargent DS, Sloan JA, Fitch TR, Krook JE, O'Connell MJ, Mailliard JA, Tirona MT, Tschetter LK, Cobau CD, Goldberg RM. A phase II trial and quality of life analysis of a five day regimen of oral 5-fluorouracil (5-FU) bracketed by a seven day regimen of oral eniluracil in untreated patients with unresectable or metastatic colorectal carcinoma. J Clin Oncol. December 2002.
22. Sloan JA, Varricchio C. Quality of life endpoints in prostate chemoprevention trials. Urology. 2001;57(supplement 4A):235-240.
23. Pepe MS. Inference for events with dependent risks in multiple endpoint studies. J Am Stat Assoc. 1991;86:770-778.
24. SAS Institute Inc. SAS/GRAPH® Software: Reference. Version 6. First Edition, Volume 1. Cary, NC: SAS Institute Inc.; 1990.