Incidence of severe adverse events (≥grade 3) per treatment arm
Treatment arm . | FC (139) . | FCA (133) . | . | ||||||
---|---|---|---|---|---|---|---|---|---|
Grade . | All . | 3 . | 4 . | 5 . | All . | 3 . | 4 . | 5 . | P . |
Infections, all: | 70 | 63 | 2 | 5 | 81 | 67 | 8 | 6 | NS |
Neutropenic | 28 | 24 | 2 | 2 | 26 | 25 | 1 | 0 | NS |
Non-neutropenic | 31 | 31 | 0 | 0 | 27 | 21 | 3 | 3 | NS |
Opportunistic | 11 | 8 | 0 | 3 | 28 | 21 | 4 | 3 | .002 |
Organ-related | 13 | 10 | 2 | 1 | 36 | 33 | 1 | 2 | .0005 |
Flulike syndrome | 3 | 3 | 0 | 0 | 27 | 27 | 0 | 0 | <.0001 |
Allergy | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | NS |
Hemorrhage | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | NS |
Other cancer | 2 | 1 | 0 | 1 | 2 | 1 | 0 | 1 | NS |
Total | 91 | 80 | 4 | 7 | 147 | 128 | 10 | 9 | <.0001 |
Total related | 80 | 70 | 4 | 6 | 118 | 104 | 9 | 5 | <.0001 |
Patients affected | 53 | 82 | .0001 | ||||||
Patients affected by related SAEs | 48 | 68 | .0057 |
Treatment arm . | FC (139) . | FCA (133) . | . | ||||||
---|---|---|---|---|---|---|---|---|---|
Grade . | All . | 3 . | 4 . | 5 . | All . | 3 . | 4 . | 5 . | P . |
Infections, all: | 70 | 63 | 2 | 5 | 81 | 67 | 8 | 6 | NS |
Neutropenic | 28 | 24 | 2 | 2 | 26 | 25 | 1 | 0 | NS |
Non-neutropenic | 31 | 31 | 0 | 0 | 27 | 21 | 3 | 3 | NS |
Opportunistic | 11 | 8 | 0 | 3 | 28 | 21 | 4 | 3 | .002 |
Organ-related | 13 | 10 | 2 | 1 | 36 | 33 | 1 | 2 | .0005 |
Flulike syndrome | 3 | 3 | 0 | 0 | 27 | 27 | 0 | 0 | <.0001 |
Allergy | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | NS |
Hemorrhage | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | NS |
Other cancer | 2 | 1 | 0 | 1 | 2 | 1 | 0 | 1 | NS |
Total | 91 | 80 | 4 | 7 | 147 | 128 | 10 | 9 | <.0001 |
Total related | 80 | 70 | 4 | 6 | 118 | 104 | 9 | 5 | <.0001 |
Patients affected | 53 | 82 | .0001 | ||||||
Patients affected by related SAEs | 48 | 68 | .0057 |