嚴重不良事件 (Chinese Wikipedia)

Analysis of information sources in references of the Wikipedia article "嚴重不良事件" in Chinese language version.

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Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.. JAMA. 2001, 285 (4): 437–43. PMID 11242428. doi:10.1001/jama.285.4.437 .
Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms.. Ann Intern Med. 2005, 142 (12 Pt 2): 1090–0. PMID 15968034. doi:10.7326/0003-4819-142-12_part_2-200506211-00009 .
Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement.. Ann Intern Med. 2004, 141 (10): 781–8. PMID 15545678. doi:10.7326/0003-4819-141-10-200411160-00009.

CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline (PDF). European Medicines Agency. June 1995 [5 October 2021]. （原始内容存档 (PDF)于2022-07-28）. NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.

What is a Serious Adverse Event?. FDA. 9 September 2020 [2021-12-20]. （原始内容存档于2018-01-25）.
Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting. (PDF). FDA Center for Drug Evaluation and Research. August 25, 2007 [2021-12-20]. （原始内容存档 (PDF)于2009-05-11）.
Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Guideline for Industry Structure and Content of Clinical Study Reports. (PDF). FDA Center for Drug Evaluation and Research. August 25, 2007 [2021-12-20]. （原始内容存档 (PDF)于2009-05-25）.

Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.. JAMA. 2001, 285 (4): 437–43. PMID 11242428. doi:10.1001/jama.285.4.437 .
Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms.. Ann Intern Med. 2005, 142 (12 Pt 2): 1090–0. PMID 15968034. doi:10.7326/0003-4819-142-12_part_2-200506211-00009 .
Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement.. Ann Intern Med. 2004, 141 (10): 781–8. PMID 15545678. doi:10.7326/0003-4819-141-10-200411160-00009.

What is a Serious Adverse Event?. FDA. 9 September 2020 [2021-12-20]. （原始内容存档于2018-01-25）.
Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting. (PDF). FDA Center for Drug Evaluation and Research. August 25, 2007 [2021-12-20]. （原始内容存档 (PDF)于2009-05-11）.
CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline (PDF). European Medicines Agency. June 1995 [5 October 2021]. （原始内容存档 (PDF)于2022-07-28）. NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.
Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Guideline for Industry Structure and Content of Clinical Study Reports. (PDF). FDA Center for Drug Evaluation and Research. August 25, 2007 [2021-12-20]. （原始内容存档 (PDF)于2009-05-25）.