with enzalutamide exposure. However, using the information from Table 12 and the associated patient narratives, it can be seen that a number of the reported malignancies are of the same histological type and may be amalgamated: Of the four patients with cancer’ all had adenocarcinoma of the stomach. ‘gastric Of the six patients with cancer’, five had a histological diagnosis of ‘colorectal adenocarcinoma. The remaining subject had a clinical diagnosis of ‘rectal carcinoma’ but no histological diagnosis was made. Of the four patients with lung cancer, the patient in the placebo arm had a histological diagnosis of adenocarcinoma whereas among the three patients in the enzalutamide arm two had a diagnosis of adenocarcinoma and one of small cell lung cancer of the lung. Of the five patients with cancer of the kidney or urinary all had a histological diagnosis of transitional cell carcinoma. Table 12: Reported malignancies. Enzalutamide Placebo (N=871) Gastric Number of patients, (% of total) 3 (0.34%) 1 carcinoma (0.12%) 95% CI for incidence 0.1, 1.0 0.02, 0.6 Age, years. Median (IQR) 73 (69, 80) 77 Time on study at diagnosis, days. 341 (212, 523) 120 Median (IQR) Colorectal Number of patients 6 (0.69%) 0 (0%) carcinoma 0.32, 1.5 0, 0.4 Age, years. Median (IQR) 67 (64,72) - Time on at diagnosis, days. 202 (130, 251) - Median (IQR) Lung Number of patients 3 (0.34%) 1 (0.12%) 0.1, 1.0 0.02, 0.6 Age, years. Median (IQR) 69 (66, 74) 77 Time on study at diagnosis, days. 361 (338, 469) 58 Median (IQR) Transitional Number of patients 5 (0.57%) 0 (0%) cell cancer of the 0.2, 1.3 0, 0.4
with enzalutamide exposure. However, using the information from Table 12 and the associated patient narratives, it can be seen that a number of the reported malignancies are of the same histological type and may be amalgamated: Of the four patients with ‘gastric cancer’ all had adenocarcinoma of the stomach. Of the six patients with ‘colorectal cancer’, five had a histological diagnosis of adenocarcinoma. The remaining subject had a clinical diagnosis of ‘rectal carcinoma’ but no histological diagnosis was made. Of the four patients with lung cancer, the patient in the placebo arm had a histological diagnosis of adenocarcinoma whereas among the three patients in the enzalutamide arm two had a diagnosis of adenocarcinoma and one of small cell lung cancer of the lung. Of the five patients with cancer of the kidney or urinary all had a histological diagnosis of transitional cell carcinoma. Table 12: Reported malignancies. Enzalutamide (N=871) Placebo Gastric carcinoma Number of patients, (% of total) 3 (0.34%) 1 (0.12%) 95% CI for incidence 0.1, 1.0 0.02, 0.6 Age, years. Median (IQR) 73 (69, 80) 77 Time on study at diagnosis, days. Median (IQR) 341 (212, 523) 120 Colorectal carcinoma Number of patients 6 (0.69%) 0 (0%) 0.32, 1.5 0, 0.4 Age, years. Median (IQR) 67 (64,72) - Time on at diagnosis, days. Median (IQR) 202 (130, 251) - Lung Number of patients 3 (0.34%) 1 (0.12%) 0.1, 1.0 0.02, 0.6 Age, years. Median (IQR) 69 (66, 74) 77 Time on study at diagnosis, days. Median (IQR) 361 (338, 469) 58 Transitional cell cancer of the Number of patients 5 (0.57%) 0 (0%) 0.2, 1.3 0, 0.4