Study: NCT00854087

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Atypical Chest Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Opiod Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 59 at risk

Adverse event: Pleomorphic Rhabdomyosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 59 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 59 at risk

Adverse event: Gastrointestinal disorders such as nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 59 at risk

Adverse event: General disorders such as fatigue
Serious: no
Organ System: General disorders
Frequency: 27 affected / 59 at risk

Adverse event: Infections such as urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 59 at risk

Adverse event: Respiratory such as cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 59 at risk

Adverse event: Nervous system disorders such as headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 59 at risk

Adverse event: Psychiatric disorders such as depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 59 at risk

Adverse event: Skin and subcutaneous system disorders such as rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 59 at risk

Adverse event: Injury, posioning and procedural complications such as muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 59 at risk

Adverse event: Investigations such as liver biopsy
Serious: no
Organ System: Investigations
Frequency: 6 affected / 59 at risk

Adverse event: Surgical and medical procedures such as knee surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 59 at risk

Adverse event: Metabolism and nutrition disorders such as decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 59 at risk

Adverse event: Renal and urinary disorders such as nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 59 at risk

Adverse event: Vascular disorders such as hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 59 at risk

Adverse event: Cardiac disorders such as tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: Eye disorders such as dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 59 at risk

Adverse event: Immune system disorders such as rhinitis allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 59 at risk

Adverse event: Ear disorders such as vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 59 at risk

Adverse event: Neoplasms such as ovarian cysts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 59 at risk

Adverse event: Reproductive system disorders such as erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 59 at risk

Adverse event: Hepatobiliary disorders (acute cholecistitis)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 59 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Alcohol rehabilitation
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 59 at risk

Adverse event: T-12 Compression
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 59 at risk

Adverse event: Transverse Myelilitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Ovarian adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 59 at risk

Adverse event: Acute Hepatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Hypokalemia/Hyponatremia/Nausea/Vomiting
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 59 at risk

Adverse event: Gastrointestinal disorders such as nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 59 at risk

Adverse event: General disorders such as fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 59 at risk

Adverse event: Infections such as urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 59 at risk

Adverse event: Respiratory such as cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 59 at risk

Adverse event: Nervous system disorders such as headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 59 at risk

Adverse event: Psychiatric disorders such as depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 59 at risk

Adverse event: Skin and subcutaneous system disorders such as rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 59 at risk

Adverse event: Injury, posioning and procedural complications such as muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 59 at risk

Adverse event: Investigations such as liver biopsy
Serious: no
Organ System: Investigations
Frequency: 8 affected / 59 at risk

Adverse event: Surgical and medical procedures such as knee surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 59 at risk

Adverse event: Metabolism and nutrition disorders such as decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 59 at risk

Adverse event: Renal and urinary disorders such as nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 59 at risk

Adverse event: Vascular disorders such as hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 59 at risk

Adverse event: Cardiac disorders such as tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 59 at risk

Adverse event: Eye disorders such as dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 59 at risk

Adverse event: Immune system disorders such as rhinitis allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 59 at risk

Adverse event: Ear disorders such as vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 59 at risk

Adverse event: Neoplasms such as ovarian cysts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 59 at risk

Adverse event: Reproductive system disorders such as erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 59 at risk

Adverse event: Endocrine disorders (hypothyroidism)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 59 at risk

Adverse event: Social circumstances (alcohol rehabilitation)
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 59 at risk