Tamaki Fushimi; Wakako Horiki; Sonoko Ishihara; Kazuhiro Kemmotsu; Tatsuo Kishi; Chie Kojima; Emiko Kondo; Hideyuki Kondou; Ministry of Health, Labour and Kemji Kuramochi; Tetsuya Kusakabe; Kaori Welfare/Pharmaceuticals and Medical Devices Nomura; Izumi Oba; Shinichi Okamura; Agency Yoshihiko Sano; Nogusa Takahara; Kenichi Tamiya; Daisuke Tanaka; Shinichi Watanabe; Takashi Yasukawa; Go Yamamoto; Manabu Yamamoto; Nobuhiro Yamamoto David Goldsmith; Sidney Kahn; Anna-Lisa Pharmaceutical Research and Manufacturers Kleckner; Susan M. Lorenski; Margaret M. of America Westland† Miles Braun; Andrea Feight; John (Jake) US Food and Drug Administration Kelsey†; Brad Leissa; Toni Piazza-Hepp † Former Rapporteur Figures OTHER TERMINOLOGY MedDRA Version 18.0 No. of No. of EVENTS EVENTS PREFERRED TERMS PREFERRED TERMS Infection 15 Upper respiratory tract infection 7 Nasopharyngitis Infection 2 Lower respiratory tract infection 1 Skin infection 4 1 Abdominal pain 9 Abdominal pain 4 Abdominal pain upper 3 Abdominal tenderness 2 Accidental injury 4 Injury 1 Laceration 1 Ligament sprain 1 Back injury 1
Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency Tamaki Fushimi; Wakako Horiki; Sonoko Ishihara; Kazuhiro Kemmotsu; Tatsuo Kishi; Chie Kojima; Emiko Kondo; Hideyuki Kondou; Kemji Kuramochi; Tetsuya Kusakabe; Kaori Nomura; Izumi Oba; Shinichi Okamura; Yoshihiko Sano; Nogusa Takahara; Kenichi Tamiya; Daisuke Tanaka; Shinichi Watanabe; Takashi Yasukawa; Go Yamamoto; Manabu Yamamoto; Nobuhiro Yamamoto Pharmaceutical Research and Manufacturers of America David Goldsmith; Sidney Kahn; Anna-Lisa Kleckner; Susan M. Lorenski; Margaret M. Westland† US Food and Drug Administration Miles Braun; Andrea Feight; John (Jake) Kelsey†; Brad Leissa; Toni Piazza-Hepp † Former Rapporteur Figures OTHER TERMINOLOGY PREFERRED TERMS No. of EVENTS MedDRA Version 18.0 PREFERRED TERMS No. of EVENTS Infection 15 Upper respiratory tract infection Nasopharyngitis Infection Lower respiratory tract infection Skin infection 7 2 1 4 1 Abdominal pain 9 Abdominal pain Abdominal pain upper Abdominal tenderness 4 3 2 Accidental injury 4 Injury Laceration Ligament sprain Back injury 1 1 1 1
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