Table 83: Characteristics of the cases identified by the sponsor in their signal analysis by searching for Preferred Terms related to gastrointestinal perforation as part of the end-of-first-round s31 response to clinical question 12. Relevant concurrent Outcome Source AE term Age Relevant history medication (yrs) dose systemic Fatal pivotal Study Italy 1200 intestinal perforation 69 concurrent diverticulitis corticosteroid NP28673 mg Recovered surveillance study Japan 600 rectal perforation (and 79 brachytherapy for prostate cancer at ALC1401 mg diverticulum intestinal the site of perforation, history of haemorrhagic) diverticulitis Recovered surveillance study 600 gastrointestinal perforation 70 concurrent ALC1401 mg systemic Recovered expanded access USA 1200 perforated diverticulitis 69 concurrent diverticulosis corticosteroid ML29453 mg systemic compassionate use France 1200 gastrointestinal perforation 43 concurrent diverticulosis corticosteroid MO29499 mg systemic Not surveillance study Japan 600 gastrointestinal perforation 69 advanced disease stage corticosteroid recovered ALC1401 mg systemic Recovered compassionate use 900 perforated sigmoid 64 sigmoid diverticulitis corticosteroid MO29499 mg Recovered pivotal Study China 900 perforated appendicitis 27 appendicitis NP28673 mg none reported Recovered spontaneous Japan 600 intestinal perforation 74 none reported mg
Table 83: Characteristics of the cases identified by the sponsor in their signal analysis by searching for Preferred Terms related to gastrointestinal perforation as part of the end-of-first-round s31 response to clinical question 12. Source dose AE term Age (yrs) Relevant history Relevant concurrent medication Outcome pivotal Study NP28673 Italy 1200 mg intestinal perforation 69 concurrent diverticulitis systemic corticosteroid Fatal surveillance study ALC1401 Japan 600 mg rectal perforation (and diverticulum intestinal haemorrhagic) 79 brachytherapy for prostate cancer at the site of perforation, history of diverticulitis Recovered surveillance study ALC1401 600 mg gastrointestinal perforation 70 concurrent Recovered expanded access ML29453 USA 1200 mg perforated diverticulitis 69 concurrent diverticulosis systemic corticosteroid Recovered compassionate use MO29499 France 1200 mg gastrointestinal perforation 43 concurrent diverticulosis systemic corticosteroid surveillance study ALC1401 Japan 600 mg gastrointestinal perforation 69 advanced disease stage systemic corticosteroid Not recovered compassionate use MO29499 900 mg perforated sigmoid 64 sigmoid diverticulitis systemic corticosteroid Recovered pivotal Study NP28673 China 900 mg perforated appendicitis 27 appendicitis Recovered spontaneous Japan 600 mg intestinal perforation 74 none reported none reported Recovered
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