Table 1.
Subject Disposition
| |
RCT |
OLE |
|
|---|---|---|---|
| Ziprasidone | Placebo | Ziprasidone | |
| Screened | 342 | N/A | |
| Assigned to treatment | 284a | 221 | |
| Treated, n | 193 | 90 | 221 |
| Completed, n (%) | 135 (69.9) | 52 (57.8) | 76 (34.4) |
| Discontinued, n (%) | 58 (30.1) | 38 (42.2) | 145 (65.6) |
| Reason for discontinuation, n (%) | |||
| Subject died | N/A | N/A | 1 (0.5)d |
| Related to study drug | 15 (7.8) | 3 (3.3) | 97 (43.9) |
| Adverse event | 13 (6.7) | 3 (3.3) | 5 (2.3) |
| Laboratory abnormality | 1 (0.5) | - | N/A |
| Study terminated by sponsor | 1 (0.5) | - | 92 (41.6) |
| Not related to study drug | 43 (22.3) | 35 (38.9) | 47 (21.3) |
| Adverse event | 8 (4.1) | 7 (7.8) | 16 (7.2) |
| Laboratory abnormality | 0 | 1 (1.1) | 1 (0.5) |
| Lost to follow-up | 3 (1.6) | 3 (3.3) | 3 (1.4) |
| Other | 18 (9.3) | 22 (24.4) | 14 (6.3) |
| Insufficient clinical response | 18 (9.3)b | 18 (20.0)b | 6 (2.7) |
| Miscellaneous | 0 | 4 (4.4)c | 8 (3.6)e |
| Withdrawal of consent | 14 (7.3) | 2 (2.2) | 13 (5.9) |
One subject was randomized but untreated.
Includes withdrawal of subject because of lack of efficacy, insufficient clinical response, and worsening of disease under study.
Includes one subject who needed to travel, one subject who was enrolled into OLE phase by investigator, one subject who had a protocol violation, and one subject who terminated RCT phase to roll over to OLE phase.
Subject committed suicide.
Includes grandparents who terminated their rights to the participant, subject who needed to reside in residential facility that did not permit research subjects, subject whose guardian withdrew consent, and withdrawal because of the sponsor's decision (subject did not follow protocol).
N/A, not applicable; OLE, open-label extension; RCT, randomized controlled trial.