Table 3.
Cumulative incidence of adverse events post-baseline for patients enrolled in Trial XXXX, based on investigator-reported CTCAE and patient-reported PRO-CTCAE.
| Adverse Event | Any Level (>0) | High-Level* | ||||
|---|---|---|---|---|---|---|
| Control | Manuka§ | Control | Manuka§ | |||
| Anorexia | CTCAE: | 24% | 21% | 2% | 1% | |
| PRO-CTCAE: |
Severity Interference |
76% 54% |
89% 74% |
26% 20% |
27% 27% |
|
| Anxiety | CTCAE: | 9% | 6% | – | – | |
| PRO-CTCAE: |
Frequency Severity Interference |
74% 72% 50% |
90% 89% 59% |
22% 20% 15% |
27% 20% 18% |
|
| Concentration impairment | CTCAE: | 2% | 2% | – | – | |
| PRO-CTCAE: |
Severity Interference |
67% 48% |
70% 56% |
9% 9% |
4% 10% |
|
| Constipation | CTCAE: | 28% | 24% | – | 1% | |
| PRO-CTCAE: | Severity | 74% | 81% | 17% | 30% | |
| Cough | CTCAE: | 30% | 34% | – | 1% | |
| PRO-CTCAE: |
Severity Interference |
93% 61% |
94% 71% |
26% 20% |
18% 16% |
|
| Depression | CTCAE: | 2% | 4% | – | – | |
| PRO-CTCAE (sad feelings): |
Frequency Severity Interference |
74% 74% 48% |
87% 84% 60% |
11% 11% 11% |
18% 13% 13% |
|
| PRO-CTCAE (nothing can cheer you up): |
Frequency Severity Interference |
57% 54% 35% |
70% 61% 45% |
7% 9% 7% |
13% 10% 10% |
|
| Radiation dermatitis | CTCAE: | 26% | 22% | 2% | 1% | |
| PRO-CTCAE: | Severity | 54% | 61% | 9% | 10% | |
| Diarrhea | CTCAE: | 20% | 15% | – | 1% | |
| PRO-CTCAE: | Frequency | 61% | 61% | 15% | 12% | |
| Dry mouth | CTCAE: | 7% | 7% | – | – | |
| PRO-CTCAE: | Severity | 65% | 79% | 11% | 11% | |
| Dry skin | CTCAE: | 11% | 2% | – | – | |
| PRO-CTCAE: | Severity | 67% | 73% | 4% | 9% | |
| Dysgeusia | CTCAE: | 13% | 13% | – | – | |
| PRO-CTCAE: | Severity | 80% | 84% | 17% | 15% | |
| Dyspepsia | CTCAE: | 22% | 9% | – | – | |
| PRO-CTCAE: |
Frequency Severity |
76% 76% |
80% 80% |
33% 28% |
27% 18% |
|
| Dysphagia | CTCAE: | 37% | 38% | – | 2% | |
| PRO-CTCAE: | Severity | 76% | 86% | 33% | 23% | |
| Dyspnea | CTCAE: | 20% | 34% | 2% | 5% | |
| PRO-CTCAE: |
Severity Interference |
83% 65% |
90% 78% |
17% 15% |
19% 18% |
|
| Fatigue | CTCAE: | 61% | 50% | 7% | 1% | |
| PRO-CTCAE: |
Severity Interference |
98% 93% |
97% 93% |
37% 33% |
39% 44% |
|
| Headache | CTCAE: | 11% | 7% | – | – | |
| PRO-CTCAE: |
Frequency Severity Interference |
63% 61% 33% |
68% 65% 40% |
15% 13% 11% |
11% 5% 5% |
|
| Hiccups | CTCAE: | 2% | 5% | – | – | |
| PRO-CTCAE: |
Frequency Severity |
63% 57% |
65% 60% |
24% 11% |
13% 3% |
|
| Hoarseness | CTCAE: | 7% | 3% | – | – | |
| PRO-CTCAE: | Severity | 67% | 73% | 16% | 6% | |
| Insomnia | CTCAE: | 13% | 7% | – | 1% | |
| PRO-CTCAE: |
Severity Interference |
85% 67% |
84% 74% |
24% 13% |
22% 22% |
|
| Memory impairment | CTCAE: | 2% | 3% | – | – | |
| PRO-CTCAE: |
Severity Interference |
61% 46% |
65% 53% |
2% 2% |
4% 5% |
|
| Mucositis | CTCAE: | 4% | 7% | – | 1% | |
| PRO-CTCAE: |
Severity Interference |
35% 26% |
48% 33% |
7% 7% |
3% 3% |
|
| Nausea | CTCAE: | 37% | 34% | 2% | 1% | |
| PRO-CTCAE: |
Frequency Severity |
63% 63% |
79% 77% |
15% 7% |
16% 18% |
|
| Pain | CTCAE: | 26% | 23% | 2% | 2% | |
| PRO-CTCAE: |
Frequency Severity Interference |
78% 78% 65% |
87% 87% 71% |
37% 30% 26% |
37% 23% 28% |
|
| Pruritus | CTCAE: | 11% | 3% | – | – | |
| PRO-CTCAE: | Severity | 54% | 57% | 9% | 4% | |
| Rash maculo-papular | CTCAE: | 9% | 2% | – | – | |
| PRO-CTCAE: | Presence | 33% | 35% | – | – | |
| Skin hyperpigmentat ion | CTCAE: | 2% | 3% | – | – | |
| PRO-CTCAE: | Presence | 28% | 28% | – | – | |
| Urticaria | CTCAE: | – | – | – | – | |
| PRO-CTCAE: | Presence | 13% | 18% | – | – | |
| Voice alteration | CTCAE: | – | 6% | – | – | |
| PRO-CTCAE: | Presence | 50% | 48% | – | – | |
| Vomiting | CTCAE: | 17% | 10% | 2% | – | |
| PRO-CTCAE: |
Frequency Severity |
35% 35% |
51% 47% |
9% 9% |
4% 5% |
|
| Wheezing | CTCAE: | – | 4% | – | – | |
| PRO-CTCAE: | Severity | 54% | 65% | 9% | 11% | |
*
High-level clinician-reported adverse events are defined as CTCAE grade 3 or 4. High-level patient-reported adverse events are defined as PRO-CTCAE scores for severity items as severe or very severe; for frequency items as frequently or almost constantly; and for interference items as quite a bit or very much.
§
Manuka honey liquid and lozenge arms are collapsed into a single Manuka group for this table.