Table 4.
Assessment points | No. | IV Mean ± S.D. | No. | IV/IP Mean ± S.D. | Difference Mean ± S.E. |
---|---|---|---|---|---|
Baseline (pre-randomization) | 197 | 11.7 ± 3.5 | 195 | 11.0 ± 3.7 | 0.7 ± 0.36 |
Prior to cycle 4 | 173 | 14.0 ± 2.9 | 144 | 12.6 ± 3.3 | 1.4 ± 0.35 |
Change from baseline1 | 168 | 2.4 ± 3.65 | 139 | 1.5 ± 4.11 | 0.91 ±0.44 |
Note: Higher score indicates less abdominal discomfort.
Overall effect size for change in AD score from baseline to cycle 4 is 0.52 (pooled analysis of patients who provided baseline and cycle 4 responses). Patients in IV arm experienced significantly more improvement in AD from baseline to pre cycle 4 assessment. Baseline to cycle 4 change scores were significantly different between groups (p=.04). This difference diminished after treatment completion and no longer existed by one year follow up (ref JCO Feb 1, 2007).