Table 2 Incidence and maximum severity of toxicities (MedDRA classification)
Dose level 1 | Dose level 2 | ∑ | ||||||
|---|---|---|---|---|---|---|---|---|
CTC grade | 1/2 | 3 | 4 | 1/2 | 3 | 1/2 | 3 | 4 |
MedDRA Code (n = 9 events) | No. of Patients | |||||||
Infections and infestations | ||||||||
Infection | 0 | 2 | 0 | 0 | 0 | 0 | 2 | 0 |
Immune system disorders | ||||||||
Anaphylactic reaction | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
Nervous system disorders | ||||||||
Peripheral sensory neuropathy | 2 | 0 | 0 | 1 | 0 | 3 | 0 | 0 |
Eye disorders | ||||||||
Conjunctival haemorrhage | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Vision blurred | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Disorder sight | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Abnormal sensation in eye | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Vascular disorders | ||||||||
Flushing | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
Hypotension | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 0 |
Thrombophlebitis | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Dyspnoea | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
Gastrointestinal disorders | ||||||||
Abdominal pain | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
Abdominal distension | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Vomiting | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
Obstipation | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
Mucous stools | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Nausea | 3 | 0 | 0 | 2 | 0 | 5 | 0 | 0 |
Abdominal discomfort | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Epigastric discomfort | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
Skin and subcutaneous tissue disorders | ||||||||
Dermatitis | 1 | 0 | 0 | 2 | 0 | 3 | 0 | 0 |
Musculoskeletal and connective tissue disorders | ||||||||
Bone pain | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Myalgia | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Pain in extremity | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Renal and urinary disorders | ||||||||
Bladder discomfort | 2 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
General disorders and administration site conditions | ||||||||
Injection site erythema | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
Pyrexia | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 0 |
Injection site paraesthesia | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
Mucosal inflammation | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Pain | 3 | 1 | 0 | 1 | 0 | 4 | 1 | 0 |
Chills | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 0 |
Investigations | ||||||||
Blood amylase increased | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Blood bilirubin increased | 2 | 0 | 0 | 3 | 0 | 5 | 0 | 0 |
Blood pressure increased | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 0 |
Blood urea increased | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Blood urea decreased | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 0 |
C-reactive protein increased | 4 | 0 | 0 | 1 | 0 | 5 | 0 | 0 |
Blood fibrinogen increased | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Gamma-glutamyltransferase increased | 4 | 0 | 0 | 1 | 1 | 5 | 1 | 0 |
Blood glucose increased | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
Haemoglobin decreased | 4 | 0 | 0 | 2 | 0 | 6 | 0 | 0 |
Blood uric acid increased | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Blood calcium decreased | 3 | 0 | 0 | 2 | 0 | 5 | 0 | 0 |
Blood creatinine increased | 3 | 0 | 0 | 1 | 0 | 4 | 0 | 0 |
Blood lactate dehydrogenase increased | 3 | 0 | 0 | 1 | 0 | 4 | 0 | 0 |
WBC count increased | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
WBC count decreased | 1 | 1 | 0 | 2 | 0 | 3 | 1 | 0 |
Platelets decreased | 3 | 0 | 0 | 2 | 0 | 5 | 0 | 0 |
Transaminases increased | 2 | 0 | 0 | 3 | 0 | 5 | 0 | 0 |