Table 2. Summary of adverse events.
| Trait | n AEs | %AEs | n pts | % pts |
|---|---|---|---|---|
| Summary of adverse events | ||||
| Patients with ≥1 AEs | 64 | 13.7 | ||
| Total number of AEs | 73 | |||
| Discontinuation due to AEs | 29 | 39.7 | 27 | 5.8 |
| Deaths | 5 | 6.8 | 5 | 1.1 |
| Resolved | 50 | 68.5 | 43 | 67.2 |
| Types of adverse events | ||||
| Systemic (asthenia, weakness, myalgias, weight loss, anemia, neutropenia.) |
17 | 23.3 | 12 | 18.7 |
| Digestive (digestive intolerance, reflux, jaundice, abdominal pain, pancreatitis, hepatic encephalopathy, liver transplant) |
15 | 20.5 | 15 | 23.4 |
| Neuropsychiatric (insomnia, depression, anxiety, mood changes) |
14 | 19.1 | 13 | 20.3 |
| Dermatological (skin lesions, rash, pruritus) |
6 | 8.2 | 6 | 9.4 |
| Infectious (pneumonia, pyelonephritis, Shigella ileocolitis, malaria) |
5 | 6.8 | 5 | 7.8 |
| Rheumatic (arthralgia) Cancer (lymphoma, duodenal carcinoma, urothelial carcinoma) |
4 4 |
5.5 5.5 |
4 4 |
6.2 6.2 |
| Metabolic (hypercholesterolemia, onset of diabetes) |
3 | 4.1 | 3 | 4.7 |
| Cardiovascular (myocardial infarction, stroke) |
2 | 2.7 | 2 | 3.1 |
| Renal (renal insufficiency) |
2 | 2.7 | 1 | 1.6 |
| Respiratory (pulmonary thromboembolism) |
1 | 1.4 | 1 | 1.6 |
| Severity of adverse events | ||||
| Grade 3–4 (fatal or life-threatening) | 8 | 10.9 | 8 | 1.7 |
| Grade 2 (requires medical treatment or hospitalization) | 14 | 19.2 | 12 | 2.6 |
| Grade 1 (does not require major medical intervention) | 51 | 69.8 | 44 | 9.4 |
| Association of adverse events with RAL+ABC/3TC | ||||
| Related | 6 | 8.2 | 4 | 0.9 |
| Likely | 27 | 37 | 24 | 5.1 |
| Unlikely | 14 | 19.2 | 12 | 2.6 |
| Not related | 26 | 35.6 | 24 | 5.1 |
AEs: adverse event, pts: patients with AEs