Table II.
Adverse Events on Southwest Oncology Group Protocol S0433. Any Grade 4 or Grade 5 and Common (in 10% of patients or more) Grade 3 Events.
Adverse Events | n, % of Patients (total n=84) |
||
---|---|---|---|
(grade ≥ 3) | Grade 3 | Grade 4 | Grade 5 |
Cardiovascular | 6 (7%) | 1 (1%) | 2* (2%) |
Flu-like symptoms | 11 (13%) | 1 (1%) | -- |
Dehydration | -- | 1 (1%) | -- |
Other Gastrointestinal Event | -- | 1 (1%) | -- |
Haematological | |||
Haemoglobin | 12 (14%) | -- | -- |
Leucocytes | 23 (27%) | 24 (29%) | -- |
Lymphopenia | 24 (29%) | 15 (18%) | -- |
Neutrophils | 11 (13%) | 44 (52%) | -- |
Platelets | 12 (14%) | 17 (20%) | -- |
GI Haemorrhage: rectum | -- | 1 (1%) | -- |
Infection | 20 (24%) | 1 (1%) | 1* (1%) |
Pneumonitis | -- | 1 (1%) | -- |
Hyperglycaemia | -- | 1 (1%) | -- |
Hyperuricaemia | -- | 1 (1%) | -- |
Hypokalaemia | -- | 1 (1%) | -- |
Neurophathy | 9 (11%) | -- | -- |
Renal Failure | -- | -- | 1* (1%) |
Secondary Malignancy | 1 (1%) | -- | 1* (1%) |
2 cardiac ischaemia, 1 febrile neutropenia, 1 renal failure, 1 acute myeloid leukaemia GI, gastrointestinal