Table 4. Dose-limiting toxicities during the initial 6 weeks of cycle 1.
| Patient ID | Treatment | Adverse Event | Causality | Action | Outcome |
|---|---|---|---|---|---|
| 10011011 |
Tremelimumab 10 mg kg−1+PF-3512676 0.05 mg kg−1 |
Grade 3 hypothalamopituitary disorder |
Tremelimumab+PF-3512676 |
Treatment continued |
Resolved |
| 10011006 |
Tremelimumab 15 mg kg−1+PF-3512676 0.05 mg kg−1 |
Grade 3 diarrhoea |
Tremelimumab |
Temporary discontinuation of PF-3512676 |
Resolved with sequelae |
| 10011010 | Tremelimumab 15 mg kg−1+PF-3512676 0.05 mg kg−1 | Grade 3 diarrhoea | Tremelimumab | Temporary discontinuation of PF-3512676 | Resolved with sequelae |