Adverse events at CTCAE category level | Medicalrecord review | HCP surveill-ance | Patient survey | Admini-strative data | Lab/clinical values | Non specified |
---|---|---|---|---|---|---|
Gastrointestinal | 9 | 14 | 3 | Â | Â | 5 |
Neurology | 3 | 6 | 1 | Â | Â | 3 |
Cardiac General | 9 | 9 | Â | 4 | 1 | 4 |
Blood/Bone Marrow | 2 | 4 | Â | Â | 5 | 1 |
Pulmonary/Upper Respiratory | 1 | 2 | Â | Â | Â | 2 |
Hepatobiliary/Pancreas | 3 | 7 | Â | 1 | 11 | 2 |
Auditory/Ear | Â | 1 | Â | Â | Â | 1 |
Ocular/Visual | Â | 1 | Â | Â | Â | Â |
Dermatology/Skin | 1 | 4 | Â | Â | Â | 3 |
Musculoskelal/Soft Tissue | Â | 1 | Â | Â | Â | 1 |
Renal/Genitourinary | 1 | 1 | Â | Â | 2 | 2 |
Constitutional symptoms: | Â | Â | Â | Â | Â | Â |
- weight | Â | 6 | Â | Â | 12 | Â |
- other | 1 | 3 | 1 | Â | Â | Â |
Pain | 3 | 7 | 2 | Â | Â | Â |
Endocrine | Â | 1 | Â | Â | Â | Â |
Infection | Â | 1 | Â | Â | Â | 3 |
Allergy/Immunology | Â | 1 | Â | Â | Â | Â |
Sexual/Reproductive Function | 1 | Â | Â | Â | Â | Â |
Metabolic: | Â | Â | Â | Â | Â | Â |
- hypoglycaemia | 7 | 7 | 8 | Â | 3 | 5 |
- other | Â | 4 | 1 | Â | 7 | 1 |
General ADEs/Tolerability* | 3 | 12 | 3 | Â | 3 | 5 |