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_36
Snippet: All adverse events will be grouped using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 of the National Institutes of Health (NIH) (Additional file 1: Table S6 ). Adverse events will be grouped into aggregate groups and reported for the entire study period (Additional file 1: Table S7 ). All results will be summarized in terms of frequency and percentage and will be compared across study arms using Fisher's exact test. All resul.....
Document: All adverse events will be grouped using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 of the National Institutes of Health (NIH) (Additional file 1: Table S6 ). Adverse events will be grouped into aggregate groups and reported for the entire study period (Additional file 1: Table S7 ). All results will be summarized in terms of frequency and percentage and will be compared across study arms using Fisher's exact test. All results will be declared statistically significant with a p value < 0.05.
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