Table 4.
Adverse events (dose or time schedule)
Name of trial | Adverse event | Experimental arm (N) | Control arm (N) |
CALGB 9712 | |||
Anaemia grade 3/4 | 2/51 | 0/53 | |
Autoimmune haemolytic anaemia | 0/51 | 1/53 | |
Chills grade 3/4 | 0/51 | 0/53 | |
Dyspnoea grade 3/4 | 7/51 | 3/53 | |
Fatigue/malaise grade 3/4 | 0/51 | 2/53 | |
Fever grade 3/4 | 0/51 | 0/53 | |
Hypotension grade 3/4 | 3/51 | 0/53 | |
Infections | 10/51 | 12/53 | |
Myalgias grade 3/4 | 0/51 | 0/53 | |
Nausea grade 3/4 | 0/51 | 1/53 | |
Neurotoxicity | 1/51 | 1/53 | |
Neutropenia grade 3/4 | 39/51 | 21/53 | |
Thrombocytopenia grade 3/4 | 10/51 | 5/53 | |
Vomiting grade 3/4 | 0/51 | 0/53 | |
Wierda 2009 | |||
During treatment and up to 30 days following the last dose | FCO500 | FCO1000 | |
Infections grade 3/4 | 4/31 | 7/30 | |
Febrile neutropenia grade 3/4 | 3/31 | 3/30 | |
Neutropenia | 11/31 | 18/30 | |
Anaemia | 2/31 | 6/30 | |
Thrombocytopenia | 2/31 | 7/30 | |
Haemolytic anaemia grade 3/4 | 2/31 | 1/30 |