Adverse events
nausea, abdominal pain, vomiting, influenza-like illness, headache, dysgeusia, deaths, chills
ADVERSE EVENTS, INFLUENZA-LIKE ILLNESS
JNJ-54175446 was well-tolerated and all adverse events were mild to moderate. There were no deaths, serious AEs, or persistent AEs reported in this study. In group A (JNJ-54175446 early start) two TEAEs, headache and abdominal pain lead to study discontinuation. Both were classified as severe and considered by the investigator as possibly related to JNJ-54175446. In group B (JNJ-54175446 late start) the two TEAEs that lead to study discontinuation were an influenza-like illness starting at day 1 that was considered by the investigator not related to JNJ-54175446 and moderate intensity chills and nausea which were considered to be very likely related to JNJ-54175446. It should however be noted that the patient was suffering from nausea before the administration was started.Adjusting for only those patients who received JNJ-54175446, the following TEAEs were the most reported; headache (25.0%), nausea (11.5%), dysgeusia (5.8%) and vomiting (5.8%). No clinically significant changes were observed in laboratory evaluations. Changes from baseline in vital signs and ECG parameters were small and not considered clinically relevant.