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All adverse events were categorized as mild.
The two other dropouts reported pneumonia and suspected cardiac arrhythmia, which were both categorized as severe adverse events not related to the study material.
Thus uncertainty in causation is categorized as causing the adverse event.
If comorbidities were related to therapy, as judged by the evaluator, the therapy was categorized as 'terminated for adverse events'; consequently, comorbiditities that – in the opinion of the physician – were unrelated to therapy (either present before and deteriorating, or newly occurring during treatment) were not regarded as reasons for termination for adverse events.
One significant unexpected adverse event was classified as possibly related to vaccine administration: exacerbation of sleep apnea in a cohort 2 volunteer several months after malaria infection associated with a 15 pound weight gain (categorized as a serious adverse event, due to accelerating the need for hospital admission for corrective surgery).
We categorized SNPs as adverse or protective on the basis of their coefficient in the CV model (relative to the minor allele for additive effects).
Patients were categorized as favorable risk (no adverse factors), intermediate risk (1 to 2 adverse factors), or poor risk (3 to 6 adverse factors).
The primary outcome variable was in-flight adverse events, categorized as either major or minor.
In this proof-of-concept trial adverse events categorized as related or possibly related to vaccine occurred in only 3 individual patients; thus, characterization of AE by gender, age, or race is not considered illustrative.
Adverse events were categorized as "hardware related" if they involved problems with the device components, "biological" if there were reactions to the device or surgical procedure and "stimulation related" if they involved stimulation issues (Table 6).
No adverse effects was categorized as severe.
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