PRO distributions at enrollment and 12-month time points
| PRO assessment . | Enrollment . | 12-months . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n . | % . | Median . | Mean . | SD . | Min . | Max . | n . | % . | Median . | Mean . | SD . | Min . | Max . | |
| FACT-G: physical well-being | 158 | 99.4 | 20 | 18.8 | 6.5 | 0 | 28 | 126 | 79.2 | 22 | 20.5 | 5.6 | 5 | 28 |
| FACT-G: emotional well-being | 158 | 99.4 | 17 | 16.6 | 4.5 | 3 | 24 | 126 | 79.2 | 18 | 17.6 | 4 | 4 | 24 |
| FACT-G: social well-being | 158 | 99.4 | 21 | 19.7 | 6.1 | 1 | 28 | 126 | 79.2 | 21 | 20.2 | 5.7 | 2.8 | 28 |
| FACT-G: functional well-being | 158 | 99.4 | 15.6 | 15.7 | 6.7 | 0 | 28 | 126 | 79.2 | 17 | 16.8 | 6 | 0 | 28 |
| FACT-G: total | 158 | 99.4 | 74.3 | 70.8 | 19 | 22 | 105 | 126 | 79.2 | 77 | 75.2 | 16.8 | 31 | 104 |
| BPI: severity | 154 | 96.9 | 1.6 | 2.3 | 2.5 | 0 | 8 | 123 | 77.4 | 0 | 1.9 | 2.5 | 0 | 8 |
| BPI: interference | 154 | 96.9 | 0.4 | 2.4 | 3 | 0 | 10 | 123 | 77.4 | 0 | 1.9 | 2.8 | 0 | 10 |
| BPI: total | 154 | 96.9 | 1.2 | 2.4 | 2.7 | 0 | 8.9 | 124 | 78 | 0 | 2 | 2.6 | 0 | 9.1 |
| Clinically relevant pain | 75 | 49 | 52 | 42 | ||||||||||
| BFI: severity | 154 | 96.9 | 4.7 | 4.1 | 2.9 | 0 | 9.3 | 122 | 76.7 | 3.7 | 3.6 | 3.3 | 0 | 9 |
| BFI: interference | 154 | 96.9 | 3.3 | 3.5 | 3.1 | 0 | 10 | 122 | 76.7 | 2.9 | 3 | 3.1 | 0 | 10 |
| BFI: total | 154 | 96.9 | 3.7 | 3.7 | 3 | 0 | 9.8 | 122 | 76.7 | 3.4 | 3.2 | 3 | 0 | 9.6 |
| Clinically relevant fatigue | 110 | 71 | 72 | 59 | ||||||||||
| Top 3 ECD-SS symptoms: severity | 154 | 96.9 | 7 | 6.7 | 2.2 | 0 | 10 | 122 | 76.7 | 6 | 5.5 | 2.6 | 0 | 10 |
| Top 5 ECD-SS symptoms: severity | 154 | 96.9 | 6.6 | 6.4 | 2.1 | 0 | 10 | 122 | 76.7 | 5.3 | 5.2 | 2.4 | 0 | 10 |
| Top ECD-SS symptom: other | 52 | 33 | 30 | 34 | ||||||||||
| Top ECD-SS symptom: neurologic | 58 | 37 | 34 | 39 | ||||||||||
| Top ECD-SS symptom: GI | 10 | 6 | 7 | 8 | ||||||||||
| Top ECD-SS symptom: pain | 27 | 17 | 11 | 13 | ||||||||||
| Top ECD-SS symptom: vision | 5 | 3 | 2 | 2 | ||||||||||
| Top ECD-SS symptom: respiratory | 6 | 4 | 3 | 3 | ||||||||||
| Unmet health care service needs | 58 | 38 | 33 | 28 | ||||||||||
| Unmet psychological/emotional needs | 90 | 58 | 56 | 45 | ||||||||||
| Unmet physical and daily health needs | 90 | 57 | 63 | 50 | ||||||||||
| Unmet care and support needs | 37 | 24 | 19 | 15 | ||||||||||
| Unmet sexual needs | 37 | 25 | 26 | 22 | ||||||||||
| No. of unmet needs | 159 | 100 | 4 | 7 | 7.4 | 0 | 29 | 125 | 78.6 | 3 | 5 | 6.2 | 0 | 31 |
| ≥3 unmet needs | 100 | 63 | 64 | 51 | ||||||||||
| ≥5 unmet needs | 79 | 50 | 49 | 39 | ||||||||||
| ≥10 unmet needs | 48 | 30 | 26 | 21 | ||||||||||
| PRO assessment . | Enrollment . | 12-months . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n . | % . | Median . | Mean . | SD . | Min . | Max . | n . | % . | Median . | Mean . | SD . | Min . | Max . | |
| FACT-G: physical well-being | 158 | 99.4 | 20 | 18.8 | 6.5 | 0 | 28 | 126 | 79.2 | 22 | 20.5 | 5.6 | 5 | 28 |
| FACT-G: emotional well-being | 158 | 99.4 | 17 | 16.6 | 4.5 | 3 | 24 | 126 | 79.2 | 18 | 17.6 | 4 | 4 | 24 |
| FACT-G: social well-being | 158 | 99.4 | 21 | 19.7 | 6.1 | 1 | 28 | 126 | 79.2 | 21 | 20.2 | 5.7 | 2.8 | 28 |
| FACT-G: functional well-being | 158 | 99.4 | 15.6 | 15.7 | 6.7 | 0 | 28 | 126 | 79.2 | 17 | 16.8 | 6 | 0 | 28 |
| FACT-G: total | 158 | 99.4 | 74.3 | 70.8 | 19 | 22 | 105 | 126 | 79.2 | 77 | 75.2 | 16.8 | 31 | 104 |
| BPI: severity | 154 | 96.9 | 1.6 | 2.3 | 2.5 | 0 | 8 | 123 | 77.4 | 0 | 1.9 | 2.5 | 0 | 8 |
| BPI: interference | 154 | 96.9 | 0.4 | 2.4 | 3 | 0 | 10 | 123 | 77.4 | 0 | 1.9 | 2.8 | 0 | 10 |
| BPI: total | 154 | 96.9 | 1.2 | 2.4 | 2.7 | 0 | 8.9 | 124 | 78 | 0 | 2 | 2.6 | 0 | 9.1 |
| Clinically relevant pain | 75 | 49 | 52 | 42 | ||||||||||
| BFI: severity | 154 | 96.9 | 4.7 | 4.1 | 2.9 | 0 | 9.3 | 122 | 76.7 | 3.7 | 3.6 | 3.3 | 0 | 9 |
| BFI: interference | 154 | 96.9 | 3.3 | 3.5 | 3.1 | 0 | 10 | 122 | 76.7 | 2.9 | 3 | 3.1 | 0 | 10 |
| BFI: total | 154 | 96.9 | 3.7 | 3.7 | 3 | 0 | 9.8 | 122 | 76.7 | 3.4 | 3.2 | 3 | 0 | 9.6 |
| Clinically relevant fatigue | 110 | 71 | 72 | 59 | ||||||||||
| Top 3 ECD-SS symptoms: severity | 154 | 96.9 | 7 | 6.7 | 2.2 | 0 | 10 | 122 | 76.7 | 6 | 5.5 | 2.6 | 0 | 10 |
| Top 5 ECD-SS symptoms: severity | 154 | 96.9 | 6.6 | 6.4 | 2.1 | 0 | 10 | 122 | 76.7 | 5.3 | 5.2 | 2.4 | 0 | 10 |
| Top ECD-SS symptom: other | 52 | 33 | 30 | 34 | ||||||||||
| Top ECD-SS symptom: neurologic | 58 | 37 | 34 | 39 | ||||||||||
| Top ECD-SS symptom: GI | 10 | 6 | 7 | 8 | ||||||||||
| Top ECD-SS symptom: pain | 27 | 17 | 11 | 13 | ||||||||||
| Top ECD-SS symptom: vision | 5 | 3 | 2 | 2 | ||||||||||
| Top ECD-SS symptom: respiratory | 6 | 4 | 3 | 3 | ||||||||||
| Unmet health care service needs | 58 | 38 | 33 | 28 | ||||||||||
| Unmet psychological/emotional needs | 90 | 58 | 56 | 45 | ||||||||||
| Unmet physical and daily health needs | 90 | 57 | 63 | 50 | ||||||||||
| Unmet care and support needs | 37 | 24 | 19 | 15 | ||||||||||
| Unmet sexual needs | 37 | 25 | 26 | 22 | ||||||||||
| No. of unmet needs | 159 | 100 | 4 | 7 | 7.4 | 0 | 29 | 125 | 78.6 | 3 | 5 | 6.2 | 0 | 31 |
| ≥3 unmet needs | 100 | 63 | 64 | 51 | ||||||||||
| ≥5 unmet needs | 79 | 50 | 49 | 39 | ||||||||||
| ≥10 unmet needs | 48 | 30 | 26 | 21 | ||||||||||
GI, gastrointestinal.