Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi.
Nkwopara E, Schmicker R, Mvalo T, Phiri M, Phiri A, Couasnon M, McCollum ED, Ginsburg AS.
Nkwopara E, et al. Among authors: ginsburg as.
BMJ Open Respir Res. 2019 Sep 3;6(1):e000415. doi: 10.1136/bmjresp-2019-000415. eCollection 2019.
BMJ Open Respir Res. 2019.
PMID: 31548894
Free PMC article.
Clinical Trial.
In the amoxicillin group, there were 46 SAEs and 5 (10.9%) cases were identified as possibly related to study drug (4 gastroenteritis and 1 fever). There were no life-threatening pneumonia SAEs or deaths in either group, and by the time of exit from the study, all children …
In the amoxicillin group, there were 46 SAEs and 5 (10.9%) cases were identified as possibly related to study drug (4 gastroenteritis …