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4. Postmarketing surveillance of nivolumab plus ipilimumab combination therapy in Japanese patients with unresectable malignant melanoma.

Author

Yamazaki, Naoya, Kiyohara, Yoshio, Uhara, Hisashi, Tsuchida, Tetsuya, Yoshida, Ai, Yamada, Takako, and Komoto, Akira

Abstract

Although malignant melanoma is relatively rare in Japan, it is often diagnosed at a later stage than in Western countries. Nivolumab and ipilimumab are immune checkpoint inhibitors targeting programmed death 1 and cytotoxic T‐lymphocyte‐associated protein 4, respectively. Owing to their complementary anticancer effects, nivolumab and ipilimumab combination therapy (N + I) has been studied and approved for treating malignant melanoma in various countries including Japan. Real‐world postmarketing surveillance was implemented to record treatment‐related adverse events (TRAEs) in patients treated with N + I following its approval in Japan. Patients were eligible for registration if they had unresectable malignant melanoma and started N + I between September 2018 and August 2019. The observation period was 13 weeks from starting N + I. Only safety information was collected and evaluated. The final case report form lock was March 2021. Overall, 173 patients (median age, 66.0 years; performance status 0–1, 88.4%; skin: 53.2%; mucosal: 32.4%) were eligible for the analyses. Overall, 34.1% of patients completed 4 doses of N + I. N + I was discontinued by 63.0% (due to adverse events in 67.9% and disease progression/death in 22.9%). Any grade and grade ≥3 TRAEs were reported in 73.41% and 52.02%, respectively. TRAEs in ≥10 patients were hepatic function abnormal (any grade/grade ≥3: 23.12%/13.29%), pyrexia (10.40%/0.58%), diarrhea (9.25%/2.89%), rash (8.67%/0.58%), hypophysitis (5.78%/5.20%), interstitial lung disease (5.78%/2.89%), and liver disorder (5.78%/4.62%). TRAEs were classified as recovered (36.99% of patients), recovering (44.51%), unrecovered (13.29%), recovered with sequelae (2.31%), and death (1.73%). Overall, 24 of 34 patients (70.59%) with gastrointestinal‐related and 53 of 65 (81.54%) liver‐related TRAEs received treatment, such as a steroid with/without an immunosuppressant; most patients recovered within 1 to 2 months. In conclusion, this postmarketing surveillance of N + I in patients with unresectable malignant melanoma revealed no new safety concerns compared with results of prior studies. Immune‐related TRAEs were generally manageable by appropriate treatment including a steroid. [ABSTRACT FROM AUTHOR]

Published
2023
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5. Nationwide surveillance of bacterial respiratory pathogens conducted by the Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology in 2009: general view of the pathogens’ antibacterial susceptibility

Author

Watanabe, Akira, Yanagihara, Katsunori, Matsumoto, Tetsuya, Kohno, Shigeru, Aoki, Nobuki, Oguri, Toyoko, Sato, Junko, Muratani, Tetsuro, Yagisawa, Morimasa, Ogasawara, Kazuhiko, Koashi, Naoto, Kozuki, Tsuneo, Komoto, Akira, Takahashi, Yoshisaburo, Tsuji, Toshikatsu, Terada, Michinori, Nakanishi, Kunio, Hattori, Rikizo, Hirako, Yukio, Maruo, Akinori, Minamitani, Shinichi, Morita, Kohei, Wakamura, Tomotaro, Sunakawa, Keisuke, Iwata, Satoshi, Iwamoto, Aikichi, Ezaki, Takayuki, Onodera, Shoichi, Kusachi, Shinya, Tateda, Kazuhiro, Tanaka, Michio, Totsuka, Kyoichi, Niki, Yoshihito, Matsumoto, Tetsuro, Kadota, Junichi, Morinaga, Yoshitomo, Honma, Yasuo, Hanaki, Hideaki, Ohsaki, Yoshinobu, Honda, Yasuhito, Sasaoka, Shoichi, Takeda, Hiroaki, Ikeda, Hideki, Sugai, Atsuko, Miki, Makoto, Nakanowatari, Susumu, Takahashi, Hiroshi, Utagawa, Mutsuko, Kobayashi, Nobuyuki, Takasaki, Jin, Konosaki, Hisami, Aoki, Yasuko, Shoji, Michi, Goto, Hajime, Saraya, Takeshi, Kurai, Daisuke, Okazaki, Mitsuhiro, Kobayashi, Yoshio, Katono, Yasuhiro, Kawana, Akihiko, Saionji, Katsu, Miyazawa, Naoki, Sato, Yoshimi, Watanuki, Yuji, Kudo, Makoto, Ehara, Shigeru, Tsukada, Hiroki, Imai, Yumiko, Watabe, Nobuei, Aso, Sakura, Mikamo, Hiroshige, Yamagishi, Yuka, Takesue, Yoshio, Wada, Yasunao, Nakamura, Tadahiro, Mitsuno, Noriko, Mikasa, Keiichi, Kasahara, Kei, Uno, Kenji, Sano, Reiko, Miyashita, Naoyuki, Kurokawa, Yukinori, Takaya, Mariko, Shimizu, Satomi, Kuwabara, Masao, Watanabe, Yaeko, Doi, Masao, Negayama, Kiyoshi, Hiramatsu, Kazufumi, Honda, Junichi, and Fujita, Masaki

Published
2012
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8. Corrigendum to “Nationwide surveillance of bacterial respiratory pathogens conducted by the Surveillance Committee of Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology in 2009: General view of the pathogens' antibacterial susceptibility” [J Infect Chemother 18 (2012) 609–620]

Author

Watanabe, Akira, Yanagihara, Katsunori, Matsumoto, Tetsuya, Kohno, Shigeru, Aoki, Nobuki, Oguri, Toyoko, Sato, Junko, Muratani, Tetsuro, Yagisawa, Morimasa, Ogasawara, Kazuhiko, Koashi, Naoto, Kozuki, Tsuneo, Komoto, Akira, Takahashi, Yoshisaburo, Tsuji, Toshikatsu, Terada, Michinori, Nakanishi, Kunio, Hattori, Rikizo, Hirako, Yukio, Maruo, Akinori, Minamitani, Shinichi, Morita, Kohei, Wakamura, Tomotaro, Sunakawa, Keisuke, Hanaki, Hideaki, Ohsaki, Yoshinobu, Honda, Yasuhito, Sasaoka, Shoichi, Takeda, Hiroaki, Ikeda, Hideki, Sugai, Atsuko, Miki, Makoto, Nakanowatari, Susumu, Takahashi, Hiroshi, Utagawa, Mutsuko, Kobayashi, Nobuyuki, Takasaki, Jin, Konosaki, Hisami, Aoki, Yasuko, Shoji, Michi, Goto, Hajime, Saraya, Takeshi, Kurai, Daisuke, Okazaki, Mitsuhiro, Kobayashi, Yoshio, Katono, Yasuhiro, Kawana, Akihiko, Saionji, Katsu, Miyazawa, Naoki, Sato, Yoshimi, Watanuki, Yuji, Kudo, Makoto, Ehara, Shigeru, Tsukada, Hiroki, Imai, Yumiko, Watabe, Nobuei, Aso, Sakura, Honma, Yasuo, Mikamo, Hiroshige, Yamagishi, Yuka, Takesue, Yoshio, Wada, Yasunao, Nakamura, Tadahiro, Mitsuno, Noriko, Mikasa, Keiichi, Kasahara, Kei, Uno, Kenji, Sano, Reiko, Miyashita, Naoyuki, Kurokawa, Yukinori, Takaya, Mariko, Kuwabara, Masao, Watanabe, Yaeko, Doi, Masao, Shimizu, Satomi, Negayama, Kiyoshi, Kadota, Junichi, Hiramatsu, Kazufumi, Morinaga, Yoshitomo, Honda, Junichi, Fujita, Masaki, Iwata, Satoshi, Iwamoto, Aikichi, Ezaki, Takayuki, Onodera, Shoichi, Kusachi, Shinya, Tateda, Kazuhiro, Tanaka, Michio, Totsuka, Kyoichi, Niki, Yoshihito, and Matsumoto, Tetsuro

Published
2015
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12. Putin's youth main asset in Russia poll

Author

Komoto, Akira

Subjects
Business, Business, international
Abstract

With nearly 60 percent of public support, acting Russian President Vladimir Putin is considered the top contender in the March 26 presidential election, thanks to his youthfulness, said Georgy Shakhnazarov, [...]

Published
2000

13. Mito Annual 96 : Private Room

Author

Asai, Toshihiro, Shinohara, Mototaki, Komoto, Akira, Asai, Toshihiro, Shinohara, Mototaki, and Komoto, Akira

Abstract

"This catalog divides into two parts : 'Compiled Data' and 'Compiled Records'. The former includes reference plates, text pages and the brief chronologies of the artists, and the latter contains photographs of the exhibition rooms and notes on the works." --page [2] of document.

Published
1996

15. walKand clpPMutations Confer Reduced Vancomycin Susceptibility in Staphylococcus aureus

Author

Shoji, Mitsutaka, Cui, Longzhu, Iizuka, Risa, Komoto, Akira, Neoh, Hui-min, Watanabe, Yukiko, Hishinuma, Tomomi, and Hiramatsu, Keiichi

Abstract

ABSTRACTVancomycin-intermediate Staphylococcus aureus(VISA) is generated from vancomycin-susceptible Staphylococcus aureusby multiple spontaneous mutations. We previously reported that sequential acquisition of mutations in the two-component regulatory systems vraSRand graRSwas responsible for the VISA phenotype of strain Mu50. Here we report on the identification of a novel set of regulator mutations, a deletion mutation in two-component regulatory system walRK(synonyms, vicRKand yycFG), and a truncating mutation in a proteolytic regulatory gene, clpP, responsible for the raised vancomycin resistance in a laboratory-derived VISA strain, LR5P1-V3. The contributory effect of the two mutations to vancomycin resistance was confirmed by introducing the walKand clpPmutations into the vancomycin-susceptible parent strain N315LR5P1 by a gene replacement procedure. The vancomycin MIC of N315LR5P1 was raised from 1 to 2 mg/liter by the introduction of the walKor clpPmutation, but it was raised to 4 mg/liter by the introduction of both the walKand clpPmutations. The vancomycin MIC value of the double mutant was equivalent to that of strain LR5P1-V3. Like VISA clinical strains, LR5P1-V3 and the double mutant strain LR5P1walK*clpP* exhibited a thickened cell wall, slow growth, and decreased autolytic activity. Transcriptional profiles of the mutants with gene replacements demonstrated that introduction of both the walKand clpPmutations could alter expression of dozens or hundreds of genes, including those involved in cell envelope and cellular processes, intermediary metabolism, and information pathway. A mutation prevalence study performed on 39 worldwide clinical VISA strains showed that 61.5, 7.7, 10.3, and 20.5% of VISA strains harbored mutations in walRK, clpP, graRS, and vraSR, respectively. The mutation of walRKwas most frequently carried by VISA strains. Together, these results suggested that the mutations of walKand clpPidentified in LR5P1-V3 constitute a new combination of genetic events causing vancomycin resistance in Staphylococcus aureus.

Published
2011
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16. A Free-Flight Support System

Author

AZUMA, Akira, TOMITA, Bunji, IUCHI, Matsusaburo, MISHIMA, Hideo, IWATA, Tadami, and KOMOTO, Akira

Subjects
ComputerApplications_COMPUTERSINOTHERSYSTEMS
Abstract

This is the second part of the report titled "A New Running Test Facility for the Study of Flight Dynamics" [1]. A support system for free flight of a model aircraft simulated to V/STOL plane or helicopter has been constructed as an additional equipment for the running test facility. The support system is consisted of a free-flight follower and a data reduction system. The free-flight follower can be carried on a carriage moving on a track and supports the model as it can fly either freely or in partly constrained freedom. The flight path and attitude angles of the model during flight can be sensed with potentiometers on the support system and recorded in oscillograms or stored in memories of a miniature computer through an A-D converter, a part of or all of which are boarded on the carriage as the data reduction system. By analyzing the data the aero and/or flight dynamic characteristics of the model will be obtained., 資料番号: SA2400852000

Published
1972

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