TEAEs occurring in 10% or more of patients in either part B (BV-DTIC) or part D (BV-nivolumab) (full analysis set)
| Preferred term . | Part B (n = 22), n (%) . | Part D (n = 21), n (%) . |
|---|---|---|
| Patients with any event | 22 (100) | 21 (100) |
| Peripheral sensory neuropathy | 17 (77) | 10 (48) |
| Constipation | 10 (45) | 10 (48) |
| Fatigue | 10 (45) | 16 (76) |
| Nausea | 9 (41) | 10 (48) |
| Arthralgia | 7 (32) | 7 (33) |
| Chills | 0 | 7 (33) |
| Diarrhea | 6 (27) | 10 (48) |
| Edema peripheral | 6 (27) | 3 (14) |
| Productive cough | 0 | 3 (14) |
| Pruritus | 6 (27) | 3 (14) |
| Decreased appetite | 5 (23) | 7 (33) |
| Infusion-related infection | 0 | 7 (33) |
| Dyspnea | 5 (23) | 0 |
| Fall | 5 (23) | 0 |
| Headache | 5 (23) | 4 (19) |
| Insomnia | 3 (14) | 4 (19) |
| Rash | 5 (23) | 3 (14) |
| Weight decreased | 5 (23) | 4 (19) |
| Alanine aminotransferase increased | 0 | 3 (14) |
| Alopecia | 4 (18) | 3 (14) |
| Blood bilirubin increased | 0 | 3 (14) |
| Dyspepsia | 0 | 3 (14) |
| Hyperglycemia | 0 | 3 (14) |
| Hypokalemia | 0 | 3 (14) |
| Cough | 4 (18) | 0 |
| Dizziness | 4 (18) | 5 (24) |
| Dry skin | 4 (18) | 4 (19) |
| Epistaxis | 4 (18) | 0 |
| Muscular weakness | 4 (18) | 2 (10) |
| Neck pain | 0 | 2 (10) |
| Pain | 0 | 2 (10) |
| Paresthesia | 0 | 2 (10) |
| Pyrexia | 4 (18) | 7 (33) |
| Rash maculopapular | 0 | 6 (29) |
| Lipase increased | 0 | 5 (24) |
| Abdominal pain | 3 (14) | 4 (19) |
| Abdominal discomfort | 0 | 2 (10) |
| Abdominal pain upper | 0 | 2 (10) |
| Amylase increased | 0 | 4 (19) |
| Anemia | 0 | 2 (10) |
| Back pain | 0 | 2 (10) |
| Dehydration | 0 | 2 (10) |
| Fall | 0 | 2 (10) |
| Hyperkalemia | 0 | 2 (10) |
| Hyponatremia | 0 | 2 (10) |
| Malaise | 0 | 2 (10) |
| Aspartate aminotransferase increased | 0 | 4 (19) |
| Asthenia | 3 (14) | 0 |
| Myalgia | 3 (14) | 4 (19) |
| Oral candidiasis | 0 | 4 (19) |
| Pain in extremity | 0 | 4 (19) |
| Neutropenia | 3 (14) | 0 |
| Night sweats | 3 (14) | 3 (14) |
| Peripheral motor neuropathy | 3 (14) | 5 (24) |
| Urinary tract infection | 3 (14) | 0 |
| Vomiting | 3 (14) | 4 (19) |
| Preferred term . | Part B (n = 22), n (%) . | Part D (n = 21), n (%) . |
|---|---|---|
| Patients with any event | 22 (100) | 21 (100) |
| Peripheral sensory neuropathy | 17 (77) | 10 (48) |
| Constipation | 10 (45) | 10 (48) |
| Fatigue | 10 (45) | 16 (76) |
| Nausea | 9 (41) | 10 (48) |
| Arthralgia | 7 (32) | 7 (33) |
| Chills | 0 | 7 (33) |
| Diarrhea | 6 (27) | 10 (48) |
| Edema peripheral | 6 (27) | 3 (14) |
| Productive cough | 0 | 3 (14) |
| Pruritus | 6 (27) | 3 (14) |
| Decreased appetite | 5 (23) | 7 (33) |
| Infusion-related infection | 0 | 7 (33) |
| Dyspnea | 5 (23) | 0 |
| Fall | 5 (23) | 0 |
| Headache | 5 (23) | 4 (19) |
| Insomnia | 3 (14) | 4 (19) |
| Rash | 5 (23) | 3 (14) |
| Weight decreased | 5 (23) | 4 (19) |
| Alanine aminotransferase increased | 0 | 3 (14) |
| Alopecia | 4 (18) | 3 (14) |
| Blood bilirubin increased | 0 | 3 (14) |
| Dyspepsia | 0 | 3 (14) |
| Hyperglycemia | 0 | 3 (14) |
| Hypokalemia | 0 | 3 (14) |
| Cough | 4 (18) | 0 |
| Dizziness | 4 (18) | 5 (24) |
| Dry skin | 4 (18) | 4 (19) |
| Epistaxis | 4 (18) | 0 |
| Muscular weakness | 4 (18) | 2 (10) |
| Neck pain | 0 | 2 (10) |
| Pain | 0 | 2 (10) |
| Paresthesia | 0 | 2 (10) |
| Pyrexia | 4 (18) | 7 (33) |
| Rash maculopapular | 0 | 6 (29) |
| Lipase increased | 0 | 5 (24) |
| Abdominal pain | 3 (14) | 4 (19) |
| Abdominal discomfort | 0 | 2 (10) |
| Abdominal pain upper | 0 | 2 (10) |
| Amylase increased | 0 | 4 (19) |
| Anemia | 0 | 2 (10) |
| Back pain | 0 | 2 (10) |
| Dehydration | 0 | 2 (10) |
| Fall | 0 | 2 (10) |
| Hyperkalemia | 0 | 2 (10) |
| Hyponatremia | 0 | 2 (10) |
| Malaise | 0 | 2 (10) |
| Aspartate aminotransferase increased | 0 | 4 (19) |
| Asthenia | 3 (14) | 0 |
| Myalgia | 3 (14) | 4 (19) |
| Oral candidiasis | 0 | 4 (19) |
| Pain in extremity | 0 | 4 (19) |
| Neutropenia | 3 (14) | 0 |
| Night sweats | 3 (14) | 3 (14) |
| Peripheral motor neuropathy | 3 (14) | 5 (24) |
| Urinary tract infection | 3 (14) | 0 |
| Vomiting | 3 (14) | 4 (19) |
TEAEs are presented and defined as newly occurring (not present at baseline) or worsening after first dose of study drugs. Summaries are sorted by decreasing frequencies in preferred terms. When a patient reported >1 TEAE that was coded to the same preferred term, the patient was counted only once for that specific preferred term.