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Criteria for safety evaluation of antimicrobial agents

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Journal of Infection and Chemotherapy

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References

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Authors and Affiliations

  1. Research Division for Development of Anti-Infective Agents, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Japan

    Akira Watanabe

  2. Infection Control and Prevention Center, Gunma University Hospital, Maebashi, Japan

    Yutaka Tokue

  3. Shinrakuen Hospital, Niigata, Japan

    Nobuki Aoki

  4. Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan

    Tetsuro Matsumoto

  5. Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki, Japan

    Katsunori Yanagihara

  6. Department of Infectious, Respiratory, and Digestive Medicine, Faculty of Medicine, University of the Ryukyus, Okinawa, Japan

    Futoshi Higa

  7. Daiichi-Sankyo Co., Ltd, Tokyo, Japan

    Hiroyuki Tsuge & Hiromi Matsuoka

  8. Pfizer Japan Inc, Tokyo, Japan

    Masahito Nagashima

  9. Meiji Seika Kaisha Ltd, Tokyo, Japan

    Yuji Sasagawa & Masato Matsumoto

  10. Toyama Chemical Co., Ltd, Tokyo, Japan

    Kazuo Fujimaki & Kenji Taguchi

  11. Shionogi & Co., Ltd, Osaka, Japan

    Mari Ariyasu

  12. Sanofi-Aventis K.K., Tokyo, Japan

    Norifumi Yamamoto

  13. Teikyo University, Tokyo, Japan

    Otohiko Kunii

  14. The Jikei University School of Medicine, Tokyo, Japan

    Kohya Shiba

  15. Japanese Society of Chemotherapy, Nichinai Kaikan B1, 3-28-8 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan

    Akira Watanabe

Authors
  1. Akira Watanabe
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  2. Yutaka Tokue
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  3. Nobuki Aoki
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  4. Tetsuro Matsumoto
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  5. Katsunori Yanagihara
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  6. Futoshi Higa
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  7. Hiroyuki Tsuge
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  8. Masahito Nagashima
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  9. Hiromi Matsuoka
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  10. Yuji Sasagawa
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  11. Masato Matsumoto
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  12. Kazuo Fujimaki
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  13. Kenji Taguchi
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  14. Mari Ariyasu
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  15. Norifumi Yamamoto
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  16. Otohiko Kunii
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  17. Kohya Shiba
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Consortia

Japanese Society of Chemotherapy

Antimicrobial Agents Safety Evaluation Standards Committee

Corresponding author

Correspondence to Akira Watanabe.

Adverse events that are likely to occur in clinical studies of antimicrobial agents

Adverse events that are likely to occur in clinical studies of antimicrobial agents

We analyzed adverse events occurring in clinical studies of antimicrobial agents (3 drugs from 3 companies) based on the system organ class and preferred term of Medical dictionary for regulatory activities terminology (MedDRA) J/V9.0.

As shown in Table 6, in the clinical studies of antimicrobial agents, events related to “gastrointestinal disorders” are most frequently followed by “respiratory, thoracic and mediastinal disorders,” “skin and subcutaneous tissue disorders,” “general disorders and administration site conditions,” “infections and infestations,” “musculoskeletal and connective tissue disorders”, and “nervous system disorders”.

Table 6 Types and numbers of adverse events that have occurred in clinical studies of antimicrobial agents (MedDRA J/V9.0)
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Individual adverse events that occurred in clinical studies of antimicrobial agents are shown in Table 7.

Table 7 Adverse events that have occurred in clinical studies of antimicrobial agents (MedDRA J/V9.0)
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Japanese Society of Chemotherapy., Antimicrobial Agents Safety Evaluation Standards Committee., Watanabe, A. et al. Criteria for safety evaluation of antimicrobial agents. J Infect Chemother 17, 139–147 (2011). https://doi.org/10.1007/s10156-010-0183-0

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  • DOI: https://doi.org/10.1007/s10156-010-0183-0

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