GPT and congenital rubella syndrome: Seven participants (8.5%) had a serious TEAE that was related to JNJ-902 (Table 2), including vomiting and confusional state (2 participants each [2.4%]), alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, asthenia, balance disorder, CRS, fall, hyperbilirubinemia, and orthostatic hypotension (one participant each [1.2%]).