Table 2.
Summary of patient demographics, characteristics, and ADR in the ISEL and INTEREST studies.
| Study | ISEL | INTEREST | ||||||
|---|---|---|---|---|---|---|---|---|
|
|
|
|||||||
| Gefitinib | Placebo | Gefitinib | Placebo | |||||
|
|
|
|
|
|||||
| n | (%) | n | (%) | n | (%) | n | (%) | |
| Sex | ||||||||
| Total | 1129 | (100) | 563 | (100) | 733 | (100) | 733 | (100) |
| Male | 761 | (67.4) | 378 | (67.1) | 466 | (63.6) | 488 | (66.6) |
| Female | 368 | (32.6) | 185 | (32.9) | 267 | (36.4) | 245 | (33.4) |
| Race | ||||||||
| White | 843 | (74.7) | 431 | (76.6) | 550 | (75.0) | 540 | (73.7) |
| Asian | 235 | (20.8) | 107 | (19.0) | 154 | (21.0) | 169 | (23.1) |
| Black | 9 | (0.80) | 5 | (0.89) | 10 | (1.4) | 12 | (1.6) |
| Other | 42 | (3.7) | 20 | (3.5) | 19 | (2.6) | 12 | (1.6) |
| Adverse events | ||||||||
| Rash | 413 | (36.7) | 56 | (10.0) | 360 | (49.1) | 73 | (10.0) |
| Diarrhea | 309 | (27.4) | 52 | (9.3) | 255 | (34.8) | 177 | (24.1) |
| Nausea | 190 | (16.9) | 90 | (16.0) | 148 | (20.2) | 187 | (25.6) |
| Vomiting | 152 | (13.5) | 56 | (10.0) | 109 | (14.9) | 123 | (16.8) |
| Dry skin | 128 | (11.4) | 20 | (3.6) | 111 | (15.1) | 10 | (1.4) |
| Constipation | 108 | (9.6) | 71 | (12.6) | 79 | (10.8) | 121 | (16.5) |
| Pyrexia | 79 | (7.0) | 27 | (4.8) | 69 | (9.4) | 118 | (16.1) |
| Stomatitis | 68 | (6.0) | 22 | (3.9) | 67 | (9.1) | 93 | (12.7) |
| Anemia | ND | ND | 34 | (4.6) | 84 | (11.5) | ||
| Alopecia | ND | ND | 23 | (3.1) | 254 | (34.7) | ||
| Neutropenia | ND | ND | 35 | (4.8) | 514 | (70.1) | ||
| Febrile neutropenia | ND | ND | 9 | (1.2) | 72 | (9.8) | ||
| Neurotoxicity | ND | ND | 49 | (6.7) | 171 | (23.3) | ||
Abbreviation: ND, not detected.