Table 2.
Adverse events of MSC patients
| Subject ID | AE Description | Start Date | End Date | Severity | Casual Relationship | Action Taken | SAE? | SAE Reason | Outcome |
|---|---|---|---|---|---|---|---|---|---|
| MSC1 | None | ||||||||
| MSC2 | Dehydration | 4/1/15 | 4/13/15 | 1 | 1 | 2 | Y | 2 | 1 |
| MSC2 | Portal vein thrombosis | 4/22/15 | 1 | 1 | 2 | Y | 6 | 1 | |
| MSC2 | Pneumonia | 4/29/15 | 5/1/15 | 1 | 1 | 2 | Y | 2 | 1 |
| MSC2 | Pleural effusion | 6/20/15 | 6/26/15 | 1 | 1 | 1 | Y | 2 | 1 |
| MSC2 | Latent TB infection w/fever | 7/15/15 | 7/26/15 | 1 | 1 | 1 | Y | 2 | 1 |
| MSC2 | Right pleural effusion | 8/19/15 | 8/20/15 | 1 | 1 | 1 | Y | 2 | 1 |
| MSC3 | Left portal vein thrombosis | 6/1/15 | 6/20/15 | 1 | 1 | 2 | Y | 6 | 1 |
| MSC3 | Emesis | 6/11/15 | 6/18/15 | 1 | 1 | 2 | Y | 2 | 1 |
| MSC3 | Upper GI bleed | 6/11/15 | 6/18/15 | 3 | 1 | 3 | Y | 2 | 1 |
| Key | ||||
|---|---|---|---|---|
| Severity | Casual Relationship | Action Taken | SAE Reason | Outcome |
| Grade 1 = Mild | 1 = None | 1 = Life‐ threatening | 1 = Recovered | |
| Grade 2 = Moderate | 1 = Unlikely | 2 = Medication | 2 = Required hospitalization | 2 = Ongoing |
| Grade 3 = Severe | 2 = Possibly | 3 = Other | 3 = Prolonging existing hospitalization | 3 = Recovered with sequela |
| Grade 4 = Life‐ threatening | 3 = Probably | 4 = Resulting in persistent significant disability or incapacity | 4 = Fatal | |
| Grade 5 = Death | 5 = Congenital anomaly or birth defect | 5 = Unknown | ||
| 6 = Medically significant or important medical condition | ||||
| 7 = Death | ||||
Abbreviations: AE, adverse event; GI, gastrointestinal; MSC, mesenchymal stem cell; SAE, serious adverse events; TB, tuberculosis; Y, yes.