Table 3 Adverse events reported during the follow-up: SENTAD-COVID Study
Adverse events | PB-NHESC-C + standard care (n = 69) | Standard care (n = 70) | p-Value | |
|---|---|---|---|---|
Total patients affected by adverse events, n (%) | 50 (72.46) | 51 (72.85) | 0.9590a | |
Total adverse events, n (%) | n = 240 | |||
Adverse events by group, n (%) | 107 (44.58) | 133 (55.41) | 0.8206b | |
Number of serious adverse events by group (including deaths) | 35 (32.71) | 57 (42.85) | 0.1040a | |
Adverse event type | Description | |||
Total deaths, n (%) | Death | 4 (5.79) | 7 (10) | 0.5319c |
Other serious adverse events, n (%) | ||||
Severe anemia | Hemoglobin reduction < 100 g/dL | 10 (14.49) | 8 (11.42) | 0.5912 a |
Disease progression | Any score increased | 5 (7.24) | 9 (12.85) | 0.3989c |
Sepsis | Isolation of pathological fungal or bacterial from blood cultures indicating disseminated infections | 5 (7.24) | 15 (21.42) | 0.0278*c |
Acute renal failure | Hemodialysis of at least 2 days | 4 (5.79) | 6 (8.57) | 0.7447c |
Hypoxia | Oxygen saturation (SpO2) <88% | 3 (4.34) | 4 (5.71) | 0.7184c |
Acute respiratory distress syndrome | Respiratory rate >20 or <12 + SpO2 ≤ 88% + score ≥ 6 | 3 (4.34) | 5 (7.14) | 0.7184c |
Multiorgan failure | Score changed to 7 | 1 (1.44) | 3 (4.28) | 0.6195c |
Other nonserious adverse events | ||||
Increased respiratory breath rate | O2 saturation levels ≥100 | 30 (43.47) | 34 (48.57) | 0.7348a |
Hypertension | Blood pressure ≥ 120/80 mmHg | 17 (24.63) | 12 (17.14) | 0.2789a |
Fever | Temperature ≥ 38 °C | 13 (18.84) | 14 (20) | 0.8633a |
Severe decreased absolute lymphocyte count | Lymphocytes <0.8 × 109/L | 8 (11.59) | 9 (12.85) | 1.0000a |
Sinus tachycardia | Heart rate (beats/min) ≥100 | 2 (2.89) | 3 (4.28) | 1.0000c |
Sinus bradycardia | Heart rate (beats/min) < 60 | 1 (1.45) | 2 (2.85) | 1.0000c |
Hypotension | Blood pressure < 100/60 mmHg | 1 (1.45) | 2 (2.85) | 1.0000c |