Study: NCT01125917

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 354 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Intractable nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Intractable vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Acute cardiac death
Serious: yes
Organ System: General disorders
Notes: DEATH
Frequency: 1 affected / 354 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 354 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 354 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 354 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 354 at risk

Adverse event: Hepatosplenomegaly
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 354 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Helicobacter pylori
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 354 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 354 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 354 at risk

Adverse event: Implant failure left knee
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 354 at risk

Adverse event: Spinal column blood clot secondary to T11-12 laparoscopic cyst removal
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 354 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 354 at risk

Adverse event: Acute mid back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 354 at risk

Adverse event: Degenerative joint disease, right hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 354 at risk

Adverse event: Worsening of left knee OA
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 354 at risk

Adverse event: Sigmoid colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 354 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Probable seizure disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Progression of lumbar spinal stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 354 at risk

Adverse event: Acute exacerbation of COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 354 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 354 at risk

Adverse event: Placental abruption
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Poststudy SAE. Systematic and nonsystematic assessments
Frequency: 1 affected / 354 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 354 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 37 affected / 354 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 36 affected / 354 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Frequency: 32 affected / 354 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 354 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 354 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 354 at risk