Table 4

Summary of serious adverse events (SAEs)

ParameterPlaceboAIMSPRO
Number of subjects reporting SAEs33
Total number of SAEs64
Withdrawal due to AEs and SAEs21
SAE by organ systemIntestinal obstruction × 2Cerebral infarct
Panenteric dysmotilityPulmonary embolus
Viral meningitisAtrial fibrillation
PyelonephritisRespiratory tract infection
Ischaemic digital ulcer