Study: NCT04502212

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
Frequency: 2 affected / 16 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
Frequency: 1 affected / 16 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
Frequency: 1 affected / 16 at risk

Adverse event: Infusion site haemorrhage
Serious: no
Organ System: General disorders
Notes: The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
Frequency: 1 affected / 16 at risk

Adverse event: Vessel puncture site swelling
Serious: no
Organ System: General disorders
Notes: The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
Frequency: 1 affected / 16 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
Frequency: 1 affected / 16 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Notes: The skin and subcutaneous tissue disorders, GI disorders, general disorders, metabolism and nutrition disorders, nervous system disorders and vascular disorders were not attributable to the device, as no TEADEs were recorded in the study.
Frequency: 1 affected / 16 at risk