Study: NCT01318538

Adverse event: Colon Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Participant was hospitalized for colon surgery; unrelated to study
Frequency: 1 affected / 52 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One participant was hospitalized for an intestinal obstruction; another participant was hospitalized for bleeding ulcers. Both were unrelated to the study
Frequency: 1 affected / 52 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Participant experienced chest pain and was admitted to the hospital for observation; unrelated to study
Frequency: 1 affected / 52 at risk

Adverse event: Abscess
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant had abscess on leg; unrelated to study
Frequency: 1 affected / 52 at risk

Adverse event: Acute Asthma Episode
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One participant required a hospital visit; the other required an overnight hospitalization
Frequency: 1 affected / 52 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Required a visit to the emergency department
Frequency: 1 affected / 52 at risk

Adverse event: Surgical Procedure - Removal of Lymph Nodes
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Required a hospitalization
Frequency: 1 affected / 52 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Social circumstances
Notes: Required a hospitalization
Frequency: 1 affected / 52 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Notes: Participant was hospitalized for risk of suicide
Frequency: 1 affected / 52 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Required a visit to the emergency department
Frequency: 2 affected / 52 at risk

Adverse event: Broken Arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Required a visit to the emergency department
Frequency: 1 affected / 52 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Required a visit to the emergency department
Frequency: 2 affected / 52 at risk

Adverse event: Animal bite
Serious: no
Organ System: Infections and infestations
Notes: Participant received IV antibiotics for cat bite in the emergency department
Frequency: 1 affected / 52 at risk

Adverse event: Involuntary Psychiatric Hospitalization
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Notes: Participant hospitalized for dehydration; unrelated to study
Frequency: 1 affected / 106 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Participant had a seizure and went to the emergency department; unrelated to study
Frequency: 1 affected / 106 at risk

Adverse event: Overdose
Serious: yes
Organ System: General disorders
Notes: One participant overdosed on Lyrica and required a visit to the emergency department; another participant overdosed on heroin and was admitted to the hospital for one night. Both were unrelated to the study
Frequency: 2 affected / 106 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One participant was hospitalized for an intestinal obstruction; another participant was hospitalized for bleeding ulcers. Both were unrelated to the study
Frequency: 1 affected / 106 at risk

Adverse event: Post-Surgery Infection
Serious: yes
Organ System: Infections and infestations
Notes: Participant had surgery and was hospitalized overnight for a post-surgery infection; unrelated to study
Frequency: 1 affected / 106 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Participant had a stroke twice; unrelated to study
Frequency: 1 affected / 106 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Participant was hospitalized for a heart attack; unrelated to study
Frequency: 1 affected / 106 at risk

Adverse event: Death - Heart Attack
Serious: yes
Organ System: Cardiac disorders
Notes: Two participants passed away from a heart attack; both were unrelated to the study
Frequency: 2 affected / 106 at risk

Adverse event: Death - Stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Participant passed away from a stroke; unrelated to study
Frequency: 1 affected / 106 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Participant was hospitalized for anemia; unrelated to study
Frequency: 1 affected / 106 at risk

Adverse event: Back pain
Serious: yes
Organ System: Nervous system disorders
Notes: Participant hurt his back, went to the emergency department, and was admitted to the hospital. He was later diagnosed with sciatica; unrelated to study
Frequency: 1 affected / 106 at risk

Adverse event: Acute Asthma Episode
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One participant required a hospital visit; the other required an overnight hospitalization
Frequency: 1 affected / 106 at risk

Adverse event: Alcohol poisoning
Serious: no
Organ System: General disorders
Notes: Required a visit to the emergency department
Frequency: 1 affected / 106 at risk

Adverse event: Gastrointestinal Virus Hospitalization
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Required a visit to the emergency department
Frequency: 2 affected / 106 at risk

Adverse event: Fainting Episode
Serious: no
Organ System: General disorders
Notes: Required a hospitalization
Frequency: 1 affected / 106 at risk

Adverse event: Broken Arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Required a visit to the emergency department
Frequency: 1 affected / 106 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Notes: Required a visit to the emergency department
Frequency: 1 affected / 106 at risk