Table 3.
Serious Adverse Events Among BEAT Study Participants During the Treatment Period
No. | Events | Number of Participants With Any Events (n = 33) | Median Time to First Appearance | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Outcome | |
---|---|---|---|---|---|---|---|---|---|
Resolved | Deaths | ||||||||
1 | Breathlessness for evaluationa | 10 | 11th week | 1 | 4 | 1 | 4 | 8 | 2 |
2 | Fever for evaluation | 1 | 8th week | … | 1 | … | … | 1 | … |
3 | Gastritis and vomiting | 3 | 19th week | … | … | 3 | … | 3 | … |
4 | Haemoptysis | 4 | 10th week | 2 | 1 | … | 1 | 3 | 1 |
5 | Pneumothorax | 2 | 8th week | … | 2 | … | … | 2 | … |
6 | Acute exacerbation of asthma | 1 | 10th week | … | … | … | 1 | 1 | … |
7 | Anemia | 6 | 13th week | … | … | 1 | 5 | 6 | … |
8 | Peripheral neuropathyb | 1 | 21st week | … | … | … | 1 | … | … |
9 | Pancreatic enzyme elevation | 1 | 24th week | … | 1 | … | … | 1 | … |
10 | Liver enzyme elevation | 2 | 6th week | … | 2 | … | … | 2 | … |
11 | Septic shock | 1 | 4th week | … | … | … | 1 | … | 1 |
12 | Urinary tract infection | 1 | 21st week | … | … | … | … | 1 | … |
Thirty-three events in 26 patients: 5 patients had 2 events/1 patients had 3 events.
Abbreviations: COVID-19, coronavirus disease 2019; LZD, linezolid.
Three patients initially admitted for breathlessness but later they tested positive for COVID-19.
One patient developed peripheral neuropathy during the 18th week so the LZD dose was reduced and later withheld until hospital admission.