Table 2.
Adverse events among all patients who started study treatment
| Erlotinib (N=334) | Placebo (N=313) | p value | |
|---|---|---|---|
| Any event (maximum grade | |||
| 1 | 20 (6%) | 26 (8%) | .. |
| 2 | 28 (8%) | 32 (10%) | .. |
| 3 | 132 (40%) | 99 (32%) | .. |
| 4 | 120 (36%) | 120 (38%) | .. |
| Any (grade 1–4) | 300 (90%) | 277 (88%) | 0·18 |
| Any (grade 3–4)* | 252 (75%) | 219 (70%) | 0·12 |
| Any (grade 3–4) excluding rash and diarrhoea | 145 (43%) | 210 (67%) | 0·11 |
| Rash (maximum grade) | |||
| No rash or grade 0 | 67 (20%) | 201 (64%) | .. |
| A (erythema alone) | 50 (15%) | 33 (11%) | 0·09 |
| B (erythema with papules) | 59 (18%) | 8 (3%) | <0·0001 |
| C (erythema with papules and pustules) | 65 (19%) | 5 (2%) | <0·0001 |
| D (erythema with papules and confluent pustules) | 14 (4%) | 0 | <0·0001 |
| Data unavailable because of death† | 36 (11%) | 31 (10%) | .. |
| Missing data‡ | 43 (13%) | 35 (11%) | .. |
| Dyspnoea | |||
| Grade 3 (dyspnoea on walking ≥100 yards) | 91 (27%) | 87 (28%) | .. |
| Grade 4 (dyspnoea on mild exertion) | 105 (31%) | 112 (36%) | .. |
| Grade 3–4 | 196 (59%) | 199 (64%) | 0·18 |
| Specific adverse events (grade 3 or 4 only) | |||
| Fatigue | 77 (23%) | 73 (23%) | .. |
| Diarrhoea | 28 (8%) | 4 (1%) | <0·0001 |
| Anorexia | 18 (5%) | 15 (5%) | .. |
| Anaemia | 6 (2%) | 3 (1%) | .. |
| Nausea | 5 (1%) | 6 (2%) | .. |
| Pneumonitis | 5 (1%) | 1 (<1%) | .. |
| Rigor chills | 4 (1%) | 0 | .. |
| Stomatitis | 4 (1%) | 0 | .. |
| Ocular | 3 (1%) | 0 | .. |
| Vomiting | 2 (1%) | 1 (<1%) | .. |
| Constipation | 1 (<1%) | 5 (2%) | 0·08 |
| Headache | 0 | 2 (1%) | .. |
Data are n (%).
*
Results when all 670 patients were used were 72% for elotinib vs 69% for placebo (p=0·43).
†
For patients who died before the first month assessment, rash could not be recorded.
‡
No rash data available at any time, but patient was alive for >1 month.