Study: NCT01843023

Adverse event: Acute Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 144 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 144 at risk

Adverse event: Amputation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 144 at risk

Adverse event: Seizure
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 144 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 144 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 144 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 144 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 144 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 144 at risk

Adverse event: Root canal infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 144 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 144 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 12 affected / 144 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 144 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 144 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 144 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 144 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 144 at risk

Adverse event: Hepatitis C
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 144 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 144 at risk

Adverse event: Liver function test
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 144 at risk

Adverse event: Multiple allergies
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 144 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 144 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 144 at risk

Adverse event: Amputation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Athralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 144 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 144 at risk

Adverse event: Tingling in arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Cold stimulus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 144 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 144 at risk

Adverse event: Unintended pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 144 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 144 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 144 at risk

Adverse event: Drug withdrawal syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 53 affected / 144 at risk

Adverse event: Hospitalized for observation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 34 affected / 144 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 144 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 144 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 144 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 144 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 144 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 144 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 144 at risk

Adverse event: Contusion
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 144 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 144 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 144 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 144 at risk

Adverse event: Mood swings
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 144 at risk

Adverse event: Seizure
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 144 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 144 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 144 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 144 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 144 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 144 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 144 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 11 affected / 144 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 144 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 144 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 144 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 144 at risk

Adverse event: Hepatitis C
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 144 at risk

Adverse event: Multiple allergies
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 144 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 144 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 144 at risk

Adverse event: Athralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 144 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 144 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 144 at risk

Adverse event: Epidural Hemorrage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 144 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 144 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 144 at risk

Adverse event: Drug withdrawal syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 52 affected / 144 at risk

Adverse event: Acute intoxication
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 38 affected / 144 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 144 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 144 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 144 at risk

Adverse event: Intentional Self Injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Suicide attempt
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Pyelonephritis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 144 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 144 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 144 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 144 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 144 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Formication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 144 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 144 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 144 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Contusion
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 144 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 144 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 144 at risk