Table 2.
Mortality, Hospitalizations, and Adverse Events
| MSC (n = 112) |
Placebo (n = 110) |
||||
|---|---|---|---|---|---|
| Mortality* | n (%) | n (%) | Relative Risk (95% CI) | ||
| Primary endpoint, died by D 30 | 42 (37.5) | 47 (42.7) | 0.88 (0.64–1.21) | ||
| Died by D 7 | 6 (5.4) | 5 (4.5) | 1.18 (0.37–3.75) | ||
| Died by D 14 | 21 (18.8) | 24 (21.8) | 0.86 (0.51–1.45) | ||
| MSC† (n = 44; Patient D = 1,604) |
Placebo† (n = 47; Patient D = 1,511) |
||||
| Patients, n (%) | Events (Rate per 30 Pt D), n | Patients, n (%) | Events (Rate per 30 Pt D), n | Relative Rate (95% CI) | |
| Readmissions at 60 d | 2 (4.5) | 4 (0.075) | 3 (6.4) | 3 (0.060) | 1.26 (0.22–7.29) |
| Serious AEs at 30 d | MSC‡ (n = 110; Patient D = 2,807) |
Placebo‡ (n = 107; Patient D = 2,646) |
Relative Rate (95% CI) | ||
| Patients, n (%) | Events (Rate per 30 Pt D), n | Patients, n (%) | Events (Rate per 30 Pt D), n | ||
| Neoplasm/tumorigenesis | 1 (0.9) | 1 (0.011) | 0 | 0 | — |
| Cardiac arrhythmias, sustained ventricular arrhythmia | 1 (0.9) | 1 (0.011) | 1 (0.9) | 1 (0.011) | 0.94 (0.06–14.81) |
| Cardiac arrhythmias, sustained supraventricular arrhythmia | 14 (12.7) | 14 (0.150) | 6 (5.6) | 6 (0.068) | 2.20 (0.86–5.60) |
| Cardiac arrhythmias, type not specified | 1 (0.9) | 1 (0.011) | 0 | 0 | — |
| Deterioration of respiratory status | 31 (28.2) | 31 (0.331) | 26 (24.3) | 30 (0.340) | 0.97 (0.62–1.53) |
| Hepatic dysfunction | 2 (1.8) | 2 (0.021) | 1 (0.9) | 1 (0.011) | 1.89 (0.17–20.63) |
| Major infection, localized | 16 (14.5) | 18 (0.192) | 21 (19.6) | 21 (0.238) | 0.81 (0.44–1.50) |
| Major Infection, sepsis | 16 (14.5) | 17 (0.182) | 17 (15.9) | 18 (0.204) | 0.89 (0.46–1.72) |
| Multisystem organ failure | 2 (1.8) | 2 (0.021) | 4 (3.7) | 4 (0.045) | 0.47 (0.09–2.56) |
| Myocardial infarction | 0 | 0 | 2 (1.9) | 2 (0.023) | — |
| Pleural effusion | 1 (0.9) | 1 (0.011) | 3 (2.8) | 4 (0.045) | 0.24 (0.02–2.30) |
| Psychiatric episode | 1 (0.9) | 1 (0.011) | 0 | 0 | — |
| Renal dysfunction, acute renal dysfunction | 26 (23.6) | 26 (0.278) | 25 (23.4) | 26 (0.295) | 0.94 (0.57–1.57) |
| Thromboembolic event, ischemic stroke | 2 (1.8) | 2 (0.021) | 1 (0.9) | 1 (0.011) | 1.89 (0.17–20.63) |
| Thromboembolic event, systemic thromboembolism | 1 (0.9) | 1 (0.011) | 2 (1.9) | 2 (0.023) | 0.47 (0.04–5.11) |
| Thromboembolic event, venous thromboembolism | 7 (6.4) | 7 (0.075) | 3 (2.8) | 3 (0.034) | 2.20 (0.59–8.22) |
| Vasodilatory state | 7 (6.4) | 7 (0.075) | 8 (7.5) | 8 (0.091) | 0.82 (0.31–2.21) |
| Other AE | 19 (17.3) | 28 (0.299) | 15 (14.0) | 18 (0.204) | 1.47 (0.72–2.99) |
| Pneumothorax | 6 (5.5) | 7 (0.075) | 6 (5.6) | 8 (0.091) | 0.82 (0.26–2.65) |
| All serious AEs | 68 (61.8) | 167 (1.785) | 70 (65.4) | 153 (1.735) | 1.03 (0.75–1.41) |
Definition of abbreviations: AE = adverse event; CI = confidence interval; MSC = mesenchymal stromal cell.
*
Per protocol, one patient in the MSC arm who withdrew before 30 days was imputed as a death.
†
A total of 129 patients was excluded from readmission analyses (66 in the MSC group and 63 in the placebo group) because they died during the index admission or were not discharged by Day 60. Two additional patients (both in the MSC arm) are excluded for early withdrawal or unavailable index hospitalization discharge data.
‡
Safety endpoints are analyzed using the safety population, which is defined as all randomized subjects who received any amount of study product.