Table 4.
Incidence and Severity of Adverse Events for Total Participants With FAP (N=92) Taking Sulindac-Erlotinibvs Placeboa
| Grade Terminologyb | Toxicity, No. of Events (%)c |
P Value Fisher Exact Test |
|||||
|---|---|---|---|---|---|---|---|
| Sulindac-Erlotinib Group (n = 46) |
Placebo Group (n = 46) |
||||||
| None | Grade 1 | Grade 2 or 3 | None | Grade 1 | Grade 2 or 3 | ||
| Total individuals, highest grade |
3 (6.5) | 22 (47.8) | 21 (45.7)d | 13 (28.3) | 27 (58.7) | 6 (13.0)d | <.001 |
| Rash acneiform | 6 (13.0) | 28 (60.9) | 12 (26.1) | 37 (80.4) | 9 (19.6) | 0 | <.001 |
| Oral mucositis | 28 (60.9) | 15 (32.6) | 3 (6.5)d | 41 (89.1) | 5 (10.9) | 0 | .004 |
| Diarrhea | 34 (73.9) | 10 (21.7) | 2 (4.3) | 40 (87.0) | 6 (13.0) | 0 | .16 |
| Nausea | 35 (76.1) | 11 (23.9) | 0 | 40 (87.0) | 4 (8.7) | 2 (4.3) | .06 |
| Pain in extremity | 42 (91.3) | 4 (8.7) | 0 | 36 (78.3) | 8 (17.4) | 2 (4.3) | .17 |
| Dry skin | 39 (84.8) | 7 (15.2) | 0 | 39 (84.8) | 7 (15.2) | 0 (0) | >.99 |
| Abdominal pain | 42 (91.3) | 4 (8.7) | 0 | 38 (82.6) | 6 (13.0) | 2 (4.3)d | .30 |
| Dry eye (irritation) | 37 (80.4) | 9 (19.6) | 0 | 45 (97.8) | 1 (2.2) | 0 | .02 |
| Headache | 42 (91.3) | 4 (8.7) | 0 | 38 (82.6) | 5 (10.9) | 3 (6.5) | .30 |
| Fatigue | 41 (89.1) | 5 (10.9) | 0 | 41 (89.1) | 5 (10.9) | 0 | >.99 |
| Alopecia | 41 (89.1) | 5 (10.9) | 0 | 45 (97.8) | 1 (2.2) | 0 | .20 |
| Dyspepsia | 42 (91.3) | 3 (6.5) | 1 (2.2) | 44 (95.7) | 2 (4.3) | 0 | .70 |
| AST and/or ALT increase |
43 (93.5) | 2 (4.3) | 1 (2.2) | 42 (91.3) | 4 (8.7) | 0 | .70 |
| Hypertension | 43 (93.5) | 1 (2.2) | 2 (4.3) | 46 (100) | 0 | 0 | .24 |
| Hematochezia | 43 (93.5) | 1 (2.2) | 2 (4.3) | 46 (100) | 0 | 0 | .24 |
| Blurred vision | 45 (97.8) | 0 | 1 (2.2) | 46 (100) | 0 | 0 | >.99 |
Abbreviations: AST, aspartate transaminase; ALT, alanine transaminase; FAP, familial adenomatous polyposis.
a
Observed in 5% or more of patients or grade 2 or higher toxicity and possibly related to study drug. Presented as number of individuals.
b
Grade terminology was from the Common Terminology Criteria for Adverse Events from the US Department of Health and Human Services, version 4.
c
Participants could have more than 1 type of event.
d
One case with a grade 3 adverse event.