Table 1.
Participant Disposition Through the Week 240 Data Cutoff (June 24, 2021; Safety Population).
| Participants, n (%) | Randomized cohort (N=272) | Non-randomized cohort (N=99) | Total (N=371) |
|---|---|---|---|
| At week 240 data cutoff | |||
| Ongoing | 133 (49) | 23 (23) | 156 (42) |
| Completed† | 55 (20) | 25 (25) | 80 (22) |
| Withdrawn | 84 (31) | 51 (52) | 135 (36) |
| Primary reason for withdrawal‡ | |||
| Lack of efficacy | 17 (6) | 10 (10) | 27 (7) |
| Adverse event | 8 (3) | 5 (5) | 13 (4) |
| Withdrawal by participant | 10 (4) | 2 (2) | 12 (3) |
| Death§ | 11 (4) | 17 (17) | 28 (8) |
| Lost to follow-up | 12 (4) | 3 (3) | 15 (4) |
| Non-adherence with study drug | 15 (6) | 6 (6) | 21 (6) |
| Pregnancy | 2 (<1) | 0 | 2 (<1) |
| No longer meets study criteria | 7 (3) | 6 (6) | 13 (4) |
| Other¶ | 2 (<1) | 2 (2) | 4 (1) |
| At week 192 visit window | |||
| Ongoing | 200 (74) | 51 (52) | 251 (68) |
| Visit impacted by COVID-19# | 9 (5) | 2 (4) | 11 (4) |
| Completed | 0 | 0 | 0 |
| Withdrawn | 72 (26) | 48 (48) | 120 (32) |
| At week 240 visit window | |||
| Ongoing | 188 (69) | 44 (44) | 232 (63) |
| Visit impacted by COVID-19# | 44 (23) | 15 (34) | 59 (25) |
| Completed | 5 (2) | 7 (7) | 12 (3) |
| Withdrawn | 79 (29) | 48 (48) | 127 (34) |
†80 participants completed the study by the time of the week 240 database lock, though only 12 did so before their week 240 observations. ‡Each participant may have only 1 primary reason. §A total of 35 participants died. Death was recorded as the reason for withdrawal in 28/35 cases. ¶Other reasons for discontinuation were investigator decision, HIV resistance, investigator discretion due to rapid progression of the participant’s malignancy, and participant developed transportation obstacles preventing ongoing participation. #Visit missed or at least 1 assessment missed. Percentage based on number of participants ongoing at the time of the visit window.