Reproductive system and breast disorders Breast enlargement 0 0 1 0 1 Breast swelling 0 0 1 0 1 Retracted nipple 0 0 1 0 1 Sub-Total Number of 0 0 3 0 3 Reactions General disorders and administration site conditions Catheter site inflammation 0 0 1 0 1 Catheter site pain 0 0 1 0 1 Chills 0 0 7 0 7 Condition aggravated 1 0 0 0 1 Death 22 0 0 0 22 Device connection issue 0 0 1 0 1 Device occlusion 0 0 1 0 1 Drug intolerance 0 0 4 0 4 Extravasation 4 0 10 0 14 Fatigue 0 0 1 0 1 General physical health 1 0 1 0 2 deterioration Influenza like illness 0 0 1 0 1 Infusion site erythema 1 0 0 0 1 Infusion site pain 0 0 1 0 1 Infusion site swelling 1 0 0 0 1 Infusion site warmth 1 0 0 0 1 Injection site erythema 0 0 1 0 1 Injection site swelling 0 0 1 0 1 swelling 1 0 0 0 1 Oedema 0 0 2 0 2 Pain 0 0 3 0 3 Pyrexia 5 0 11 0 16 Swelling 0 0 2 0 2 Sub-Total Number of 37 0 49 0 86 Reactions Investigations Blood glucose increased 0 0 1 0 1 Glycosylated haemoglobin 0 0 1 0 1 increased Weight decreased 0 0 1 0 1 Sub-Total Number of 0 0 3 0 3 Reactions Injury, poisoning and procedural complications Drug administration error 0 0 1 0 1 Incorrect drug 0 0 1 0 1 administration rate Incorrect route of drug 0 0 1 0 1 administration Overdose 0 0 1 0 1 Procedural complication 0 0 1 0 1 drug administered 0 0 1 0 1
Reproductive system and breast disorders Breast enlargement 0 0 1 0 1 Breast swelling 0 0 1 0 1 Retracted nipple 0 0 1 0 1 Sub-Total Number of Reactions 0 0 3 0 3 General disorders and administration site conditions Catheter site inflammation 0 0 1 0 1 Catheter site pain 0 0 1 0 1 Chills 0 0 7 0 7 Condition aggravated 1 0 0 0 1 Death 22 0 0 0 22 Device connection issue 0 0 1 0 1 Device occlusion 0 0 1 0 1 Drug intolerance 0 0 4 0 4 Extravasation 4 0 10 0 14 Fatigue 0 0 1 0 1 General physical health deterioration 1 0 1 0 2 Influenza like illness 0 0 1 0 1 Infusion site erythema 1 0 0 0 1 Infusion site pain 0 0 1 0 1 Infusion site swelling 1 0 0 0 1 Infusion site warmth 1 0 0 0 1 Injection site erythema 0 0 1 0 1 Injection site swelling 0 0 1 0 1 swelling 1 0 0 0 1 Oedema 0 0 2 0 2 Pain 0 0 3 0 3 Pyrexia 5 0 11 0 16 Swelling 0 0 2 0 2 Sub-Total Number of Reactions 37 0 49 0 86 Investigations Blood glucose increased 0 0 1 0 1 Glycosylated haemoglobin increased 0 0 1 0 1 Weight decreased 0 0 1 0 1 Sub-Total Number of Reactions 0 0 3 0 3 Injury, poisoning and procedural complications Drug administration error 0 0 1 0 1 Incorrect drug administration rate 0 0 1 0 1 Incorrect route of drug administration 0 0 1 0 1 Overdose 0 0 1 0 1 Procedural complication 0 0 1 0 1 drug administered 0 0 1 0 1