Table 4.
Serious Adverse Events by System Organ Class and Preferred Term
| SAE | Progesterone Group (n = 18) [No. (%)] | Control Group (n = 22) [No. (%)] | Control Group After Progesteronea (n = 9) [No. (%)] |
|---|---|---|---|
| Any SAE or death | 2 (11.1) | 5 (22.7) | 3 (33.3) |
| Blood and lymphatic system disorders | |||
| Lymphocyte count decreased | 0 (0.0) | 1 (4.5) | 0 (0.0) |
| Cardiac disorders | |||
| Cardiac arrest | 0 (0.0) | 1 (4.5) | 0 (0.0) |
| Hypoperfusion | 0 (0.0) | 3 (13.6) | 2 (22.2) |
| Renal and urinary disorders | |||
| Creatinine increased | 0 (0.0) | 1 (4.5) | 0 (0.0) |
| Respiratory, thoracic, and mediastinal disorders | |||
| Hypoxia | 0 (0.0) | 4 (18.2) | 3 (33.3) |
| Vascular disorders | |||
| DVT | 1 (5.6) | 2 (9.1) | 1 (11.1) |
| Pulmonary embolism | 1 (5.6) | 0 (0.0) | 0 (0.0) |
| Death | 1 (5.6) | 1 (4.5) | 0 (0.0) |
SAE = serious adverse event.
a
For control patients who received progesterone due to clinical deterioration, this column represents SAEs that occurred after receiving progesterone.