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_38
Snippet: Let K be the number of stages of the current clinical trial needed to complete the trial and i ∈ {1, 2} be the index for the two-stage design in the k th stage. Let r 1ki and r 2ki be the proportions of 90 days mortality in the standard of care and treatment group respectively. Then the Z test statistic for the difference in proportion can be calculated as follows:.....
Document: Let K be the number of stages of the current clinical trial needed to complete the trial and i ∈ {1, 2} be the index for the two-stage design in the k th stage. Let r 1ki and r 2ki be the proportions of 90 days mortality in the standard of care and treatment group respectively. Then the Z test statistic for the difference in proportion can be calculated as follows:
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