Study: NCT00097695

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Hereditary angioedema
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: HAE attacks were over-reported as AEs as some investigators reported new attacks as AEs in addition to worsening of attacks in Icatibant treated patients.
Frequency: 4 affected / 27 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 27 at risk

Adverse event: Administration site conditions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hereditary angioedema
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: HAE attacks were over-reported as AEs as some investigators reported new attacks as AEs in addition to worsening of attacks in Icatibant treated patients.
Frequency: 5 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 29 at risk

Adverse event: Administration site conditions
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: HAE attack
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hereditary angioedema
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: HAE attacks were over-reported as AEs as some investigators reported new attacks as AEs in addition to worsening of attacks in Icatibant treated patients.
Frequency: 4 affected / 8 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: HAE attack
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hereditary angioedema
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: HAE attacks were over-reported as AEs as some investigators reported new attacks as AEs in addition to worsening of attacks in Icatibant treated patients.
Frequency: 17 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 49 at risk

Adverse event: Administration site conditions
Serious: no
Organ System: General disorders
Frequency: 11 affected / 49 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 49 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hereditary angioedema
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: HAE attacks were over-reported as AEs as some investigators reported new attacks as AEs in addition to worsening of attacks in Icatibant treated patients.
Frequency: 1 affected / 3 at risk

Adverse event: Administration site conditions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hereditary angioedema
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: HAE attacks were over-reported as AEs as some investigators reported new attacks as AEs in addition to worsening of attacks in Icatibant treated patients.
Frequency: 5 affected / 20 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 20 at risk

Adverse event: Administration site conditions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk