Multiple Sclerosis Research Repository

From: “Table 126: Reviewer table: Proportion of patients with CDP12 or CDPW12 by subgroup, WA25046 [PPMS trial [ORATORIO]], ITT [intention to treat]” (From: Center for Drug Evaluation and Research, Application Number: 761053Orig1s000: Medical Review(s))

1. Subgroup: Female; Treatment Effect 0.6%
2. Subgroup: Male; Treatment Effect: 5.9%
3. Subgroup: age 45 or less; Treatment Effect: 5.1%
4. Subgroup: older than 45; Treatment Effect: 1.4%
5. Subgroup: less than 75kg; Treatment Effect: 2.7%
6. Subgroup: 75kg or greater; Treatment Effect: 3.9%
7. Subgroup: 2 years or less time since diagnosis: Treatment Effect: 7.2%
8. Subgroup: 2 to 5 years since diagnosis: Treatment Effect: -1.2%
9. Subgroup: 5 to 10 years since diagnosis: Treatment effect: 0%
10. Subgroup: more than 10 years since diagnosis: 0.4%
11. Subgroup: less than or equal to 3 years since onset of MS symptoms; Treatment Effect: 4.7%
12. Subgroup: 3 to 5 years since onset of MS symptoms: Treatment Effect: 0.2%
13. Subgroup: 5 to 10 years since onset of MS symptoms; Treatment Effect: 1.6%
14. Subgroup: greater than 10 years since onset of MS symptoms; Treatment effect: 0%
15. Subgroup: 0 baseline T1 Gd enhanced lesions; treatment effect: 4.3%
16. Subgroup: 1 baseline T1 Gd enhanced lesions; treatment effect: -1.4%
17. Subgroup: 2 baseline T1 Gd enhanced lesions; treatment effect: 2%
18. Subgroup: 3 baseline T1 Gd enhanced lesions; treatment effect: 1.4%
19. Subgroup: 4 or more baseline T1 Gd enhanced lesions; treatment effect: 0.2%
20. Subgroup: baseline EDSS under 4; treatment effect: 3.1%
21. Subgroup: baseline EDSS 4 or above; treatment effect: 3.5%
22. Subgroup: baseline EDSS less than or equal to 5; treatment effect: 4.5%
23. Subgroup: baseline EDSS above 5; treatment effect: 2%
24. Subgroup: relapse free, yes; treatment effect: 2%
25. Subgroup: relapse free, no; treatment effect: 4.5%
26. Subgroup: previous MS treatment, yes; treatment effect: 2.5%
27. Subgroup: previous MS treatment, no; treatment effect: 4.1%
28. Subgroup: outside of the USA; treatment effect: 4.7%
29. Subgroup: USA; treatment effect: 1.8%