Table 2.
Treatment emergent adverse events in the CONRAD A18-146 study.
| Group 1* (N=8) |
Group 2* (N=8) |
Total (N=16) |
|
|---|---|---|---|
| Total Number of Treatment Emergent Adverse Events | 7 | 7 | 8 |
| Number (%) of Participants Reporting at Least One: | |||
| TEAE | 6 (75.0%) | 1 (12.5%) | 7 (43.8%) |
| TEAE by DAIDS Grade[1] | |||
| Grade 1: Mild | 6 (75.0%) | 1 (12.5%) | 7 (43.8%) |
| Grade 2 - 5: Moderate to Death | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| TEAE by Relationship to Study Treatment[2] | |||
| Not Related | 6 (75.0%) | 1 (12.5%) | 7 (43.8%) |
| Related | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| TEAE by Relationship to Study Procedure[2] | |||
| Not Related | 4 (50.0%) | 1 (12.5%) | 5 (31.3%) |
| Related | 2 (25.0%) | 0 (0.0%) | 2 (12.5%) |
| TEAE Leading to Discontinuation of Study TX | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| TEAE Requiring Dose Interruption of Study TX | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| TEAE Leading to Premature Withdrawal from the Study or Death | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
*Participants randomized to sampling at 4 and 48h (Group 1) or 24 and 72h (Group 2) post dosing.
AIDS, acquired immunodeficiency syndrome; DAIDS, Division of AIDS; TEAE, treatment-emergent adverse event.
[1] Participants reporting more than one adverse event were counted only once using the highest DAIDS grade.
[2] Participants reporting more than one adverse event were counted only once using the closest relationship to study treatment/procedure.