Table 5.
Evaluation of known groups validity of Ped-PRO-CTCAE item mean scores by medication use at T2*
| Medication taken for† | Ped-PRO-CTCAE symptom AE item | Did not take medication in past 7 days |
Took mediation in past 7 days |
ttest | ||
|---|---|---|---|---|---|---|
| No. | Mean (95% CI) | No. | Mean (95% CI) | P | ||
| Nausea | Nausea – F | 118 | 0.29 (0.19 to 0.39) | 299 | 0.86 (0.77 to 0.95) | <.01 |
| Nausea – S | 118 | 0.29 (0.18 to 0.40) | 298 | 0.86 (0.77 to 0.95) | <.01 | |
| Nausea – I | 118 | 0.13 (0.06 to 0.20) | 299 | 0.53 (0.45 to 0.60) | <.01 | |
| Vomiting – F | 119 | 0.13 (0.07 to 0.20) | 299 | 0.54 (0.46 to 0.61) | <.01 | |
| Vomiting – I | 119 | 0.08 (0.02 to 0.13) | 299 | 0.31 (0.24 to 0.38) | <.01 | |
| Insomnia | Insomnia – F | 328 | 0.58 (0.49 to 0.66) | 84 | 1.04 (0.84 to 1.23) | <.01 |
| Insomnia – S | 328 | 0.52 (0.44 to 0.60) | 85 | 0.95 (0.76 to 1.14) | <.01 | |
| Insomnia – I | 329 | 0.24 (0.18 to 0.30) | 84 | 0.55 (0.40 to 0.70) | <.01 | |
| Constipation | Constipation – F** | 243 | 0.20 (0.14 to 0.26) | 174 | 0.74 (0.62 to 0.85) | <.01 |
| Constipation – S | 244 | 0.15 (0.10 to 0.20) | 173 | 0.69 (0.57 to 0.81) | <.01 | |
| Constipation – I | 243 | 0.02 (0.01 to 0.04) | 174 | 0.24 (0.16 to 0.32) | <.01 | |
| Diarrhea | Diarrhea – F | 406 | 0.33 (0.27 to 0.39) | 11 | 1.00 (0.15 to 1.85) | .11 |
| Diarrhea – I | 407 | 0.09 (0.06 to 0.12) | 11 | 0.27 (0.16 to 0.71) | .37 | |
| Mucositis | Mucositis – F | 326 | 0.30 (0.24 to 0.36) | 92 | 0.97 (0.77 to 1.17) | <.01 |
| Mucositis – S | 326 | 0.29 (0.23 to 0.34) | 91 | 1.02 (0.80 to 1.24) | <.01 | |
| Mucositis – I | 327 | 0.06 (0.03 to 0.09) | 92 | 0.64 (0.45 to 0.83) | <.01 | |
| Neuropathy | Neuropathy – S | 339 | 0.29 (0.24 to 0.35) | 74 | 0.62 (0.44 to 0.80) | <.01 |
| Neuropathy – I | 338 | 0.06 (0.03 to 0.09) | 74 | 0.23 (0.10 to 0.36) | .01 | |
| Headache | Headache – F | 296 | 0.28 (0.22 to 0.33) | 117 | 0.96 (0.80 to 1.11) | <.01 |
| Headache – S | 298 | 0.26 (0.20 to 0.32) | 117 | 1.01 (0.84 to 1.17) | <.01 | |
| Headache – I | 298 | 0.12 (0.08 to 0.16) | 117 | 0.55 (0.40 to 0.70) | <.01 | |
| Depression | Depression – S | 377 | 0.44 (0.36 to 0.51) | 37 | 0.57 (0.29 to 0.85) | .36 |
| Depression – I | 376 | 0.16 (0.12 to 0.21) | 36 | 0.33 (0.12 to 0.55) | .12 | |
| Anxiety | Anxiety – F | 345 | 0.44 (0.36 to 0.51) | 69 | 0.74 (0.51 to 0.97) | .02 |
| Anxiety – S | 348 | 0.40 (0.33 to 0.47) | 69 | 0.64 (0.43 to 0.84) | .03 | |
| Anxiety – I | 348 | 0.15 (0.10 to 0.20) | 69 | 0.38 (0.18 to 0.57) | .03 | |
| Pain | Abdominal pain – F | 328 | 0.52 (0.45 to 0.59) | 90 | 0.89 (0.73 to 1.05) | <.01 |
| Abdominal pain – S | 328 | 0.50 (0.43 to 0.57) | 90 | 0.90 (0.74 to 1.06) | <.01 | |
| Abdominal pain – I | 329 | 0.26 (0.20 to 0.32) | 90 | 0.48 (0.33 to 0.63) | <.01 | |
| Pain – F | 325 | 0.50 (0.43 to 0.58) | 90 | 1.21 (1.03 to 1.39) | <.01 | |
| Pain – S | 325 | 0.51 (0.43 to 0.59) | 90 | 1.36 (1.17 to 1.54) | <.01 | |
| Pain – I | 325 | 0.30 (0.23 to 0.36) | 89 | 0.88 (0.69 to 1.07) | <.01 | |
*
Groups were considered statistically different when CIs did not overlap between children with different performance levels. AE = adverse event; CI = confidence interval; F = frequency; S = severity; I = interference; Ped-PRO-CTCAE = Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; T2 = time 2.
†Medication use was reported by the caregiver or parent.