Table 2.
Supplemental symptomatic AE information entries by study (unstructured free text entries and structured dropdown terms)
| Manuka study | PROSPECT study | Validation study | Total across studies | |
|---|---|---|---|---|
| Participants | 152 | 666 | 940 | 1760 |
| PRO-CTCAE surveys completed | 843 | 5794 | 2255 | 8892 |
| Average PRO-CTCAE surveys completed per participant | 5.5 | 8.7 | 2.4 | 5.1 |
| Supplemental symptomatic AE information entries: unstructured free text entries and structured dropdown symptomatic AE terms | ||||
| Supplemental information entries (unstructured free text + structured dropdown) | 61 | 1407 | 919 | 2387 |
| Participants who submitted either unstructured free text or structured dropdown entries | 72 (47) | 557 (84) | 395 (42) | 1024 (58) |
| Average supplemental symptomatic AE information entries per participant | 0.8 | 2.5 | 2.4 | 2.3 |
| Supplemental symptomatic AE information entries: unstructured free text entries | ||||
| Unstructured free text entriesa | 46 (6) | 720 (12) | 147 (7) | 913 (10) |
| Participants who entered unstructured free text entries | 32 (21) | 247 (37) | 111 (12) | 390 (22) |
| Average unstructured free text entries submitted per participant | 1.4 | 2.9 | 1.3 | 0.5 |
| Total items within unstructured free text entriesa | 69 | 1134 | 154 | 1357 |
| Nonsymptomatic AE items | 11 | 154 | 5 | 170 |
| Symptomatic AE items | 58 | 980 | 149 | 1187 |
| Mapped to PRO-CTCAE term | 20 | 330 | 34 | 384 |
| Unmapped to PRO-CTCAE term (mapped to MedDRA) | 38 | 650 | 115 | 803 |
| Supplemental symptomatic AE information entries: structured dropdown symptomatic AE terms | ||||
| Total structured dropdown symptomatic AE terms | 15 | 687 | 772 | 1474 |
| PRO-CTCAE | 12 | 395 | 729 | 1136 |
| MedDRA | 3 | 292 | 43 | 338 |
| Participants who selected structured dropdown symptomatic AE terms | 13 (9) | 310 (47) | 284 (30) | 634 (36) |
| Average structured dropdown symptomatic AE terms per patient | 1.2 | 2.2 | 2.7 | 2.3 |
Note:Values are n (%), unless otherwise indicated.
AE: adverse event; MedDRA: Medical Dictionary for Regulatory Activities; PRO-CTCAE: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events.
aA single free text entry might include a sentence with multiple symptom terms, and therefore would be mapped individually.