Author: Arabi, Yaseen M.; Asiri, Ayed Y.; Assiri, Abdullah M.; Aziz Jokhdar, Hani A.; Alothman, Adel; Balkhy, Hanan H.; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M.; Memish, Ziad A.; Ghazal, Sameeh; Al Faraj, Sarah; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Al Mekhlafi, Ghaleb A.; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Almotairi, Abdullah; Al Bshabshe, Ali; Kharaba, Ayman; Jose, Jesna; Al Harthy, Abdulrahman; Al Sulaiman, Mohammed; Mady, Ahmed; Fowler, Robert A.; Hayden, Frederick G.; Al-Dawood, Abdulaziz; Abdelzaher, Mohamed; Bajhmom, Wail; Hussein, Mohamed A.
Title: Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-ß1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial Document date: 2020_1_3
ID: 0cah15lg_28
Snippet: Post-randomization hospital length of stay Number of days between randomization and discharge from the hospital. Because of the competing risk effect of death on length of stay, length of stay will be also reported for survivors alone The number and percentage of reported serious adverse events any time during the study period. These SAEs include: acute pancreatitis, severe elevation of Alanine aminotransferase (ALT) to more than five-fold the up.....
Document: Post-randomization hospital length of stay Number of days between randomization and discharge from the hospital. Because of the competing risk effect of death on length of stay, length of stay will be also reported for survivors alone The number and percentage of reported serious adverse events any time during the study period. These SAEs include: acute pancreatitis, severe elevation of Alanine aminotransferase (ALT) to more than five-fold the upper normal limit, anaphylaxis, bleeding diathesis and others
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