Study: NCT01097668

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Notes: Treatment emergent = onset date is on or after the date of first dosing with IMP, and the onset date does not occur after the date of the Week 20 visit.

Non-treatment emergent = onset date is after the date of the Week 20 visit.
Frequency: 1 affected / 21 at risk

Adverse event: Injection Site Reactions
Serious: no
Organ System: General disorders
Notes: Treatment Emergent Adverse Event of mild to moderate intensity.
Frequency: 12 affected / 21 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Nasopharyngitis of mild to moderate intensity was experienced by 3 patients at the 800 μg dose level only (weeks 14 and 16).
Frequency: 3 affected / 21 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Emergent Adverse Events of moderate intensity.
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events of mild to moderate intensity.
Frequency: 3 affected / 21 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events of moderate intensity. The number of MS relapses was not unexpected for this population.
Frequency: 2 affected / 21 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events of mild intensity.
Frequency: 2 affected / 21 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject had a TEAE assessed as moderate in severity one week after the week 14 dose. This was located on the subject's back and arm whilst the injection was on the abdomen.
Frequency: 1 affected / 21 at risk

Adverse event: Injection Site Reactions
Serious: no
Organ System: General disorders
Notes: Treatment Emergent Adverse Event of mild to moderate intensity.
Frequency: 7 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Nasopharyngitis of mild to moderate intensity was experienced by 3 patients at the 800 μg dose level only (weeks 14 and 16).
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events of mild to moderate intensity.
Frequency: 3 affected / 22 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events of moderate intensity. The number of MS relapses was not unexpected for this population.
Frequency: 3 affected / 22 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adverse Events of moderate intensity.
Frequency: 2 affected / 22 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Notes: Treatment emergent = onset date is on or after the date of first dosing with IMP, and the onset date does not occur after the date of the Week 20 visit.

Non-treatment emergent = onset date is after the date of the Week 20 visit.
Frequency: 2 affected / 21 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Nasopharyngitis of mild to moderate intensity was experienced by 3 patients at the 800 μg dose level only (weeks 14 and 16).
Frequency: 1 affected / 21 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Emergent Adverse Events of moderate intensity.
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events of mild to moderate intensity.
Frequency: 1 affected / 21 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events of moderate intensity. The number of MS relapses was not unexpected for this population.
Frequency: 4 affected / 21 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Notes: Treatment emergent = onset date is on or after the date of first dosing with IMP, and the onset date does not occur after the date of the Week 20 visit.

Non-treatment emergent = onset date is after the date of the Week 20 visit.
Frequency: 1 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Nasopharyngitis of mild to moderate intensity was experienced by 3 patients at the 800 μg dose level only (weeks 14 and 16).
Frequency: 1 affected / 22 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events of moderate intensity. The number of MS relapses was not unexpected for this population.
Frequency: 4 affected / 22 at risk