| Intensive Phase (Month 0–2) n = 639 | Continuation Phase (Month 3–6) n = 596 | Follow Up Phase (Month 7–18) n = 569 | P value | ||
|---|---|---|---|---|---|
| No of Grade 3 AEs Reported | 66 | 31 | 19 | *** | |
| No. Grade 4 AEs Reported | 19 | 6 | 3 | *** | |
| System Organ Class of Reported Grade 3 & 4 AEs | |||||
| Musculoskeletal | 14 | 7 | 0 | 0.102 | |
| Metabolism & Nutrition | 11 | 0 | 6 | 0.006 | |
| General Disorders | 7 | 3 | 1 | 0.838 | |
| No of Grade 3 or 4 AEs per Patient | |||||
| 0 | 578 | 574 | 554 | <0.001 | |
| 1 | 49 | 18 | 9 | ||
| 2 | 9 | 2 | 4 | ||
| ≥3 | 3 | 2 | 2 | ||
| No of Patients with ≥1 SAE (Considered Related) | 32 (21) | 18 (6) | 20 (2) | 0.168 | |
| Mean No of SAEs per Patient | 1.78 | 1.39 | 1.60 | 0.092 | |
| No of Withdrawals | 38 | 26 | 1 | <0.001 | |
| No of Deaths | 5 | 1 | 10 | 0.014 | |