Table 2.
Treatment-emergent adverse events in a Phase 1 dose ascending study of VGT-309 in healthy volunteers.
| Treatment-Emergent Adverse Events | |||||||
|---|---|---|---|---|---|---|---|
| Subject ID | Dose (mg/kg) | Age | Sex | Weight | Adverse Event | Severity | VGT-309 Relatedness |
|
| |||||||
| 1009 | 0.016 | 32 | M | 86.5 | |||
|
| |||||||
| 1011 | 0.016 | 18 | M | 90.2 | Pain at IVC site | Mild | Unrelated |
|
| |||||||
| 1017 | 0.016 | 21 | M | 82.3 | |||
|
| |||||||
| 1019 | 0.016 | 19 | F | 67.8 | Headache | Mild | Unrelated |
|
| |||||||
| 1020 | 0.016 | 22 | M | 65 | |||
|
| |||||||
| 1021 | 0.016 | 29 | F | 79.9 | |||
|
| |||||||
| 1006 | 0.05 | 25 | M | 69.7 | |||
|
| |||||||
| 1018 | 0.05 | 22 | M | 59.5 | Nausea Lightheadedness | Mild Mild | Related Related |
|
| |||||||
| 1031 | 0.05 | 26 | M | 92.4 | |||
|
| |||||||
| 1032 | 0.05 | 22 | F | 67.9 | Menstrual cramps | Mild | Unrelated |
|
| |||||||
| 1036 | 0.05 | 42 | M | 83.6 | |||
|
| |||||||
| 1040 | 0.05 | 19 | F | 58.7 | |||
|
| |||||||
| 1045 | 0.16 | 37 | F | 73.1 | |||
|
| |||||||
| 1049 | 0.16 | 33 | M | 80.6 | |||
|
| |||||||
| 1051 | 0.16 | 21 | F | 66.5 | |||
|
| |||||||
| 1056 | 0.16 | 27 | M | 79.3 | |||
|
| |||||||
| 1059 | 0.16 | 22 | M | 70.9 | |||
|
| |||||||
| 1063 | 0.32 | 25 | M | 61.3 | Postural dizziness | Mild | Unrelated |
|
| |||||||
| 1070 | 0.32 | 51 | F | 83.5 | Nausea Headache | Mild Moderate | Unrelated Unrelated |
|
| |||||||
| 1071 | 0.32 | 19 | F | 63.7 | Nausea Lower back pain | Mild Mild | Unrelated Unrelated |
|
| |||||||
| 1073 | 0.32 | 27 | F | 63.3 | |||
|
| |||||||
| 1079 | 0.32 | 18 | M | 72.5 | Loose bowel movement Infusion related reaction Chest pain | Mild Moderate Mild | Related Related Unrelated |
|
| |||||||
| 1084 | 0.32 | 23 | F | 69.9 | |||
|
| |||||||
| 1013 | Placebo | 31 | F | 51.4 | |||
|
| |||||||
| 1024 | Placebo | 26 | F | 53.2 | |||
|
| |||||||
| 1010 | Placebo | 22 | M | 79 | |||
|
| |||||||
| 1035 | Placebo | 29 | F | 53 | |||
|
| |||||||
| 1042 | Placebo | 26 | M | 84.4 | Right IVC site bruise Left cubital fossa bruising | Mild Mild | Unrelated Unrelated |
|
| |||||||
| 1060 | Placebo | 25 | F | 55 | |||
|
| |||||||
| 1072 | Placebo | 40 | M | 92.7 | |||