Table 2. Protocol Availability for Trials in Which PEP Changes Were Detected.
| Trial protocol availability | Trials with PEP changes, No. (%)a | ||||
|---|---|---|---|---|---|
| Article | ClinicalTrials.gov | Protocol | Total changes | No change | |
| No protocol (n = 473) | 24 (5.1) | 65 (13.7) | 0 | 76 (16.1) | 397 (83.9) |
| 1 Version (n = 134) | 3 (2.2) | 22 (16.4) | 0 | 22 (16.4) | 112 (83.6) |
| Multiple versions (n = 148) | 16 (10.8) | 33 (22.3) | 41 (27.7) | 47 (31.8) | 101 (68.2) |
Abbreviation: PEP, primary end point.
a
The denominator for percentages was the number for each type of protocol availability. P < .001, by χ2 test comparing total PEP changes for each protocol type with those for no changes of the same protocol type.