Table 5. Dose-limiting toxicities after the initial 6 weeks of cycle 1.
Patient ID | Treatment | Adverse Event | Event Onset | Causality | Action | Outcome |
---|---|---|---|---|---|---|
10011013 |
Tremelimumab 10 mg kg−1+PF-3512676 0.10 mg kg−1 |
Grade 3 colitis |
Cycle 1, day 71 |
Tremelimumab |
Permanent discontinuation of tremelimumab+PF-3512676 |
Resolved |
10011016 |
Tremelimumab 10 mg kg−1+PF-3512676 0.15 mg kg−1 |
Grade 4 neutropenia
Grade 4 rectal bleeding
Grade 2 uveitis |
Cycle 3, day 8
Cycle 4, day 28
157 days after completion of cycle 4 |
PF-3512676
Tremelimumab
Tremelimumab |
Permanent discontinuation of PF-3512676
Treatment complete |
Resolved
Resolved
Resolved |
10011018 | Tremelimumab 10 mg kg−1+PF-3512676 0.15 mg kg−1 | Grade 3 colitis | Cycle 2, day 12 | Tremelimumab | Permanent discontinuation of tremelimumab+PF-3512676 | Resolved |