Table 3 Premature study termination and deaths
Patients with a 12-month observation period (SAF) [n (%)] | 39 (11.5%) |
Patients with premature study termination after start of treatment, i.e. observation period < 12 months (SAF) [n (%)] | 292 (86.4%) |
Patients alive at study termination and with data available (SAF) | 130 |
Main reasons for premature study termination (SAF) [n (%)]: | |
Tumor progression | 74 (56.9%) |
Patient’s wish | 21 (16.2%) |
Physician’s decision | 13 (10.0%) |
Absent rash | 9 (6.9%) |
Withdrawal of informed consent | 2 (1.5%) |
Lost to follow-up | 2 (1.5%) |
Toxicity of erlotinib | 1 (0.8%) |
Toxicity of gemcitabine | 1 (0.8%) |
Other | 7 (5.4%) |
Patients who started a second/further-line treatment and were alive at premature termination (SAF) [n (%)] | 43 (33.1%) |
Deaths before regular study end (SAF) | 133 |
Causes of death [n (%)]: | |
Tumor progression | 84 (63.2%) |
Pancreatic cancer | 29 (21.8%) |
Toxicity of gemcitabine | 1 (0.8%) |
Unknown | 11 (8.3%) |
Other | 8 (6.0%) |
Patients who were lost to follow-up (SAF) [n (%)] | 29 8.6%) |