Table 2.
Graded adverse events following receipt of 10–1074 and/or VRC01LS among 12 children during 12 weeks of follow-up in Phase A and in the subset of 6 children during 32 weeks of follow-up in Phase B.
| Toxicity Grade (N) | ||||
|---|---|---|---|---|
|
| ||||
| Adverse Event | Grade 1 | Grade 2 | Grade 3 | Total |
|
| ||||
| Overall, N (%) | 83 (88%) | 9 (10%) | 2 (2%) | 94 |
|
| ||||
| Abnormal laboratory results | 38 | 6 | 1 | 45 |
| Neutrophil count decreased | 8 | 2 | 0 | 10 |
| Hemoglobin decreased | 8 | 1 | 0 | 9 |
| Glucose decreased | 5 | 2 | 0 | 7 |
| Creatinine increased | 5 | 0 | 0 | 5 |
| Sodium decreased | 5 | 0 | 0 | 5 |
| Glucose increased | 3 | 0 | 0 | 3 |
| Potasium increased | 1 | 0 | 1 | 2 |
| Bicarbonate decreased | 2 | 0 | 0 | 2 |
| Calcium decreased | 1 | 0 | 0 | 1 |
| Carbon dioxide decreased | 0 | 1 | 0 | 1 |
|
| ||||
| Clinical diagnoses | 45 | 3 | 1 | 49 |
|
| ||||
| Upper respiratory tract infection | 14 | 1 | 0 | 15 |
| Isolated cough | 8 | 0 | 0 | 8 |
| Fungal skin infection | 5 | 0 | 0 | 5 |
| Rash, dermatitis or eczema | 4 | 1 | 0 | 5 |
| Abdominal pain | 4 | 0 | 0 | 4 |
| Gastroenteritis or diarrhea | 2 | 1 | 0 | 3 |
| Conjunctivitis | 2 | 0 | 0 | 2 |
| Abscess | 1 | 0 | 0 | 1 |
| Acquired phimosis | 1 | 0 | 0 | 1 |
| Blood pressure increased | 0 | 0 | 1 | 1 |
| Extremity pain | 1 | 0 | 0 | 1 |
| Oral fungal infection | 1 | 0 | 0 | 1 |
| Penile pain | 1 | 0 | 0 | 1 |
| Urinary tract infection | 1 | 0 | 0 | 1 |