Table 5 Adverse event profile for FTD/TPI in mCRC patients with ECOG ≥2
Patient No.a | ECOG | MedDRA Preferred Term | Adverse Drug Reaction | |
|---|---|---|---|---|
1 | 2 | Death | Non-related | Serious |
Oedema peripheral | Non-related | Non-serious | ||
Skin ulcer | Non-related | Non-serious | ||
General physical health deterioration | Non-related | Non-serious | ||
6b | 2 | Cough | Non-related | Non-serious |
Fatigue | Non-related | Serious | ||
Oesophagitis | Suspected | Serious | ||
37 | 2 | Urinary tract infection | Non-related | Non-serious |
45 | 2 | Abdominal Pain | Non-related | Non-serious |
Anaemia | Suspected | Serious | ||
Constipation | Non-related | Non-serious | ||
Leukopenia | Suspected | Serious | ||
Thrombocytopenia | Suspected | Serious | ||
Urinary tract infection | Suspected | Serious | ||
85 | 2 | Metastases to central nervous system | Non-related | Non-serious |
152b | 3 | Dyspnoea | Non-related | Non-serious |
210 | 2 | Dyspnoea | Non-related | Non-serious |
Fatigue | Non-related | Serious | ||
Oedema peripheral | Non-related | Non-serious | ||
General physical health deterioration | Non-related | Non-serious | ||
230 | 2 | Thrombocytopenia | Suspected | Serious |
Leukopenia | Suspected | Serious | ||
Nausea | Non-related | Non-serious | ||
248 | 3 | Nausea | Non-related | Non-serious |