Table 2 Reported serious adverse events after day 28 up to 12 months of follow-up post-hospital discharge
Group | Type of reaction/event | Relatedness of study to reaction/event | Outcome of reaction/event | Investigator’s comments | |
|---|---|---|---|---|---|
Patient 1 (event 1) | UC-MSCs | Coma | No | Death | No causality regarding this event |
Patient 1 (event 2) | UC-MSCs | Terminal extubation | No | Death | No causality regarding this event |
Patient 2 | UC-MSCs | Septic shock | No | Death | Event is related to disease progression (ARDS associated to COVID-19) |
Patient 3 | Placebo | Multiple organ failure | No | Death | Event is related to disease progression (ARDS associated to COVID-19) |