Study: NCT01130740

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 5 affected / 149 at risk

Adverse event: Outpatient Surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 2 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 1 affected / 149 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Nervous system disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 1 affected / 149 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 1 affected / 149 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 5 affected / 149 at risk

Adverse event: Outpatient Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 6 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Cardiac disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 2 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Ear and labyrinth disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 1 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Endocrine disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 3 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Gastrointestinal disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 2 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: General disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 2 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Infections and infestations
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 1 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 1 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 4 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Psychiatric disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 1 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 3 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 1 affected / 149 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Surgical and medical procedures
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 1 affected / 149 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 6 affected / 151 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 6 affected / 151 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Hepatobiliary disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 1 affected / 151 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 2 affected / 151 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 10 affected / 151 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 1 affected / 151 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 2 affected / 151 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Renal and urinary disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 1 affected / 151 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 3 affected / 151 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 11 affected / 151 at risk

Adverse event: Outpatient Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of serious but not study related adverse events for the intervention group.
Frequency: 7 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 2 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Cardiac disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 3 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Ear and labyrinth disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 1 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Endocrine disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 3 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Eye disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 1 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Gastrointestinal disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 5 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: General disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 4 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Infections and infestations
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 4 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 3 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 22 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 3 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Nervous system disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 6 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Psychiatric disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 2 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Renal and urinary disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 8 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Reproductive system and breast disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 1 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 11 affected / 151 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The intervention group had more regular contact with the study team than the usual care group. In some cases this resulted in higher rates of non-systematic reporting of non-serious and not study related adverse events for the intervention group.
Frequency: 2 affected / 151 at risk