Study: NCT01318356

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 50 at risk

Adverse event: Gastointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 50 at risk

Adverse event: Muskuloskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 50 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 50 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 50 at risk

Adverse event: Bone and teeth
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 18 affected / 50 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 52 at risk

Adverse event: Gastointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 52 at risk

Adverse event: Muskuloskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 52 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 52 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 52 at risk

Adverse event: Bone and teeth
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 52 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 24 affected / 52 at risk

Adverse event: Laboratorial
Serious: no
Organ System: Investigations
Frequency: 14 affected / 52 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Notes: One patient who had not yet started treatment was admitted to hospital with urosepsis.
Frequency: 1 affected / 52 at risk

Adverse event: Cardiological symptoms
Serious: yes
Organ System: Cardiac disorders
Notes: The other patient was admitted for clinical evaluation of preexisting cardiological symptoms, which yielded no diagnosis.
Frequency: 1 affected / 52 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 52 at risk

Adverse event: Gastointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 52 at risk

Adverse event: Muskuloskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 52 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 52 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 52 at risk

Adverse event: Bone and teeth
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 13 affected / 52 at risk

Adverse event: Laboratorial
Serious: no
Organ System: Investigations
Frequency: 7 affected / 52 at risk