Study: NCT02028208

Adverse event: Shock hypoglycaemic
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Emergency services called for insulin shock. Subject administered sugar infusion and Novorapid. Event resolved same evening. Investigator considered event serious but as it did not meet the criteria for an SAE it was not reported as such.
Frequency: 1 affected / 21 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscle pain, left side of torso
Frequency: 1 affected / 21 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Vesicles in nose
Frequency: 1 affected / 21 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Vesicles in mouth
Frequency: 1 affected / 21 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Vesicles on foot
Frequency: 1 affected / 21 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Vesicles on fingers
Frequency: 1 affected / 21 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever
Frequency: 1 affected / 21 at risk

Adverse event: Herpes
Serious: no
Organ System: Infections and infestations
Notes: Herpes zoster on the back
Frequency: 1 affected / 21 at risk

Adverse event: Lichenification
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Oral lichenoid lesions, left side
Frequency: 1 affected / 21 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus on the back at the test area
Frequency: 1 affected / 21 at risk

Adverse event: Complex regional pain
Serious: no
Organ System: Nervous system disorders
Notes: Upper back causalgia
Frequency: 1 affected / 21 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory tract infection
Frequency: 1 affected / 21 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Acne-like lesions on posterior aspect of trunk
Frequency: 1 affected / 13 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Bilateral upper arm pruritus
Frequency: 1 affected / 13 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Eczema in both axillae
Frequency: 1 affected / 13 at risk

Adverse event: Application site papules
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Papules on upper posterior aspect of trunk
Frequency: 1 affected / 13 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus on upper posterior aspect of trunk
Frequency: 1 affected / 13 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergic reaction on upper posterior aspect of trunk
Frequency: 1 affected / 22 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythematous scaling on no. 3 fingers, both hands
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 1 affected / 22 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: Herpes Zoster
Frequency: 1 affected / 22 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Itching on the back patch test sites- left side
Frequency: 2 affected / 22 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain in shoulder
Frequency: 1 affected / 22 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus on back
Frequency: 1 affected / 22 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus on the back at the test area
Frequency: 1 affected / 22 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritus on left side of back
Frequency: 2 affected / 22 at risk