Table 5.
Incidence of Severe AE and Clinically Significant Differences (CSD) in the Related PRO Items
| Toxicity | Assessment | ||
|---|---|---|---|
| Anorexia | FACT-L Losing weight |
LCSS Appetite |
SDS Appetite |
| Number evaluable* | 324 | 106 | 22 |
| AE Grade 2+ | 13% | 8% | 41% |
| AE Grade 3+ | 3% | 1% | 5% |
| CSD in QOL | 43% | 43% | 50% |
| AE 2+ and CSD in QOL | 6% | 5% | 32% |
| % Agreement AE 2+ and QOL | 56% | 59% | 73% |
| AE 3+ and CSD in QOL | 1% | 0% | 5% |
| % Agreement AE 3+ and QOL | 56% | 57% | 55% |
| Dyspnea | FACT-L Tightness in chest |
FACT-L Ease of Breathing |
LCSS Shortness of breath |
| Number evaluable* | 322 | 321 | 105 |
| AE Grade 2+ | 31% | 31% | 40% |
| AE Grade 3+ | 12% | 13% | 17% |
| CSD in QOL | 35% | 43% | 45% |
| AE 2+ and CSD in QOL | 14% | 15% | 20% |
| % Agreement AE 2+ and QOL | 62% | 55% | 55% |
| AE 3+ and CSD in QOL | 6% | 6% | 11% |
| % Agreement AE 3+ and QOL | 64% | 56% | 59% |
| Fatigue | FACT-L Have energy |
LCSS Fatigue |
SDS Fatigue |
| Number evaluable* | 334 | 105 | 22 |
| AE Grade 2+ | 37% | 58% | 46% |
| AE Grade 3+ | 11% | 19% | 18% |
| CSD in QOL | 57% | 57% | 46% |
| AE 2+ and CSD in QOL | 23% | 38% | 23% |
| % Agreement AE 2+ and QOL | 53% | 61% | 55% |
| AE 3+ and CSD in QOL | 8% | 14% | 9% |
| % Agreement AE 3+ and QOL | 47% | 52% | 55% |
| Nausea | FACT-L Nausea |
SDS Nausea incidence |
SDS Nausea severity |
| Number evaluable* | 333 | 22 | 14 |
| AE Grade 2+ | 25% | 41% | 43% |
| AE Grade 3+ | 5% | 9% | 14% |
| CSD in QOL | 47% | 27% | 21% |
| AE 2+ and CSD in QOL | 16% | 14% | 7% |
| % Agreement AE 2+ and QOL | 60% | 59% | 50% |
| AE 3+ and CSD in QOL | 3% | 5% | 0% |
| % Agreement AE 3+ and QOL | 54% | 73% | 64% |
| Confusion | FACT-L Clear thinking |
SDS Concentration |
|
| Number evaluable* | 328 | 22 | |
| AE Grade 2+ | 1% | 5% | |
| AE Grade 3+ | 1% | 5% | |
| CSD in QOL | 44% | 36% | |
| AE 2+ and CSD in QOL | 1% | 0% | |
| % Agreement AE 2+ and QOL | 57% | 59% | |
| AE 3+ and CSD in QOL | 1% | 0% | |
| % Agreement AE 3+ and QOL | 57% | 59% | |
| Constipation | SDS Bowel |
||
| Number evaluable* | 22 | ||
| AE Grade 2+ | 23% | ||
| AE Grade 3+ | 5% | ||
| CSD in QOL | 36% | ||
| AE 2+ and CSD in QOL | 18% | ||
| % Agreement AE 2+ and QOL | 77% | ||
| AE 3+ and CSD in QOL | 5% | ||
| % Agreement AE 3+ and QOL | 68% | ||
| Diarrhea | SDS Bowel |
||
| Number evaluable* | 22 | ||
| AE Grade 2+ | 5% | ||
| AE Grade 3+ | 0% | ||
| CSD in QOL | 36% | ||
| AE 2+ and CSD in QOL | 0% | ||
| % Agreement AE 2+ and QOL | 59% | ||
| AE 3+ and CSD in QOL | 0% | ||
| % Agreement AE 3+ and QOL | 63% | ||
| Arthralgia | FACT-L Physical Functioning |
SDS Pain Severity | |
| Number evaluable* | 376 | 21 | |
| AE Grade 2+ | 2% | 10% | |
| AE Grade 3+ | 0% | 0 | |
| CSD in QOL | 60% | 43% | |
| AE 2+ and CSD in QOL | 2% | 10% | |
| % Agreement AE 2+ and QOL | 41% | 67% | |
| AE 3+ and CSD in QOL | 0% | 0 | |
| % Agreement AE 3+ and QOL | 40% | 57% | |
| Headache | FACT-L Physical Functioning |
SDS Pain Severity | |
| Number evaluable* | 376 | 21 | |
| AE Grade 2+ | 2% | 5% | |
| AE Grade 3+ | 0% | 0 | |
| CSD in QOL | 60% | 43% | |
| AE 2+ and CSD in QOL | 1% | 5% | |
| % Agreement AE 2+ and QOL | 40% | 62% | |
| AE 3+ and CSD in QOL | 0 | 0 | |
| % Agreement AE 3+ and QOL | 40% | 57% | |
| Pain | FACT-L Physical Functioning |
SDS Pain Severity | |
| Number evaluable* | 376 | 21 | |
| AE Grade 2+ | 13% | 5% | |
| AE Grade 3+ | 5% | 5% | |
| CSD in QOL | 60% | 43% | |
| AE 2+ and CSD in QOL | 9% | 0 | |
| % Agreement AE 2+ and QOL | 44% | 52% | |
| AE 3+ and CSD in QOL | 3% | 0 | |
| % Agreement AE 3+ and QOL | 42% | 52% | |
*
Represents the number of patients that had an adverse event (grade specified) and completed a QOL assessment at baseline and at least once post-baseline. Does not include patients with verified baseline AE of grade 2+.