Table 4.
Variables | Univariate analysis | Multivariate analysis | |||
|
Odds ratio (95% CI)a | P value | Adjusted odds ratio (95% CI)a | P value | |
First posted date |
|
||||
|
2020 | referent | N/Ab | referent | N/A |
|
2019 | 1.17 (0.97-1.4) | .10 | 3.62 (0.8-26.08) | .13 |
|
2018 | 1.26 (1.05-1.51) | .01 | 11.9 (2.5-89.64) | .004 |
|
2017 | 1.53 (1.26-1.86) | <.001 | 21.93 (4.42-172.29) | <.001 |
Sponsor |
|
|
|
|
|
|
Industry | referent | N/A | referent | N/A |
|
Nonindustry | 0.89 (0.74-1.07) | .19 | N/A | N/A |
Multicenter study |
|
|
|
||
|
No | referent | N/A | referent | N/A |
|
Yes | 0.79 (0.65-0.95) | .01 | 0.33 (0.13-0.79) | .01 |
Multinational study |
|
|
|
|
|
|
No | referent | N/A | referent | N/A |
|
Yes | 0.83 (0.64-1.09) | .18 | N/A | N/A |
US involvement |
|
|
|
|
|
|
No | referent | N/A | referent | N/A |
|
Yes | 1.04 (0.83-1.31) | .73 | N/A | N/A |
Type of expanded access |
|
|
|
|
|
|
IPc | referent | N/A | referent | N/A |
|
ISd | 0.84 (0.71-1.0) | .05 | N/A | N/A |
|
Tr. IND/Pr.e | 0.95 (0.8-1.13) | .54 | N/A | N/A |
aFor each variable (first posted date; sponsor; multicenter study; multinational study; US involvement; type of expanded access), odds ratios and 95% CIs are shown related to the referent value.
bN/A: not applicable.
cIP: individual patients.
dIS: intermediate-size population.
eTr. IND/Pr.: Treatment IND/protocol.