Table 2.
Percentage of patients with Norfolk QOL-DN item responses indicating substantial impairment at week 66, and change in percentage from baseline to week 66, by treatment arm
| Item # | Content | Week 66 | Change from baseline to week 66 | ||
|---|---|---|---|---|---|
| Inotersen (%) | Placebo (%) | Inotersen (%) | Placebo (%) | ||
| 8 | Pain kept you awake at night | 15.5 | 36.5 | − 1.7 | 7.2 |
| 9 | Touch of bed sheets bothered you | 11.9 | 26.9 | − 1.6 | 8.0 |
| 10 | Injured yourself without feeling | 14.3 | 19.2 | 1.0 | 5.4 |
| 11 | Symptoms affect usual activity | 35.7 | 50.0 | 6.9 | 20.7 |
| 12 | Difficult movement with fingers | 46.4 | 63.5 | 1.7 | 18.6 |
| 13 | Felt unsteady on your feet | 48.8 | 67.3 | − 0.7 | 17.3 |
| 14 | Problem getting out of a chair | 50.0 | 61.5 | 3.3 | 11.5 |
| 15 | Problem walking down stairs | 41.7 | 57.7 | 0.7 | 16.3 |
| 16 | Unable to feel your feet | 45.2 | 40.4 | 10.3 | 0.7 |
| 17 | Unable to tell hot (hands) | 15.5 | 25.0 | 1.1 | 4.3 |
| 18 | Unable to tell hot (feet) | 40.5 | 38.5 | − 0.5 | 0.5 |
| 19 | Problem with vomiting | 6.0 | 5.8 | 2.1 | 2.3 |
| 20 | Problem with diarrhea | 20.2 | 30.8 | − 1.7 | 15.3 |
| 21 | Problem with fainting/dizziness | 10.7 | 19.2 | − 8.3 | 10.6 |
| 22 | Difficulty bathing | 22.6 | 34.6 | − 0.2 | 17.4 |
| 23 | Difficulty dressing | 21.4 | 34.6 | 1.4 | 22.5 |
| 24 | Difficulty walking | 40.5 | 59.6 | 3.9 | 28.6 |
| 25 | Difficulty getting on/off toilet | 22.6 | 36.5 | 2.6 | 15.8 |
| 26 | Difficulty using utensils | 19.0 | 30.8 | − 1.0 | 10.1 |
For the selected Norfolk QOL-DN items, substantial impairment was defined as a response of ‘moderate problem’ or ‘severe problem’