Exact(2)
These symptoms or conditions were classified as potential adverse related events whether recorded on the IMCI assessment form or recorded directly as an adverse related event.
Adverse related event occurrence among cohort groups is summarized in Table 5.
Similar(58)
Adverse drug reactions (adverse events related to omeprazole) are summarized in Table 6.
Adverse events (AEs) and adverse device related events (ADEs) were coded using MedDRA version 15.1.
There were no adverse events related to the formula and no serious adverse events reported.
Adverse events related to alcohol abuse and illicit drugs were not considered adverse drug events.
Importantly, adverse events related to the drug under study could unblind mutation status and adverse events related to study procedures are not limited to those receiving therapy.
Serious adverse events related to caspofungin were reported in 4 cases (3.9%); 3 patients (2.9%) discontinued treatment due to an adverse event related to caspofungin.
Tolerability assessments included treatment-emergent adverse events reports and adverse-event related study discontinuations.
And Medtronic has said it reported all adverse reactions related to Infuse to the Food and Drug Administration.
Twenty-nine (6.3%) patients reported mild adverse events related to treatment.
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