Study: NCT01382719

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Menometrorrhagia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 97 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 97 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 97 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Injection/vessel puncture site hematoma (1% each)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 97 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 97 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 97 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 97 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 97 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Abdominal pain/discomfort, lower/upper abdominal pain, dyspepsia (1% each)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 97 at risk

Adverse event: Feeling hot/jittery, inj site reac/hemorrhage/rash, pain, chest pain (1% each)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 97 at risk

Adverse event: Fungal infect, gastroenter/bronchitis, vulvo/vaginitis, follicul/pharyngitis, tooth abcess (1% each)
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 97 at risk

Adverse event: Migraine, sciatica, sinus headache (1% each)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hematoma, hot flush (1% each)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 97 at risk

Adverse event: Musculoskeletal pain/myalgia, arthralgia, muscle spasms, flank pain (1% each)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 97 at risk

Adverse event: Vag hemorrh/discharge, breast tend/mass, metrorrhagia, menstru irreg, genit discomfort/order (1% ea)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 97 at risk

Adverse event: CPK/glu/lipase/chol/BP/triglycerides increased, iron decreased, MCV abnormal (1% each)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 97 at risk

Adverse event: Acne, pruritis, dermatitis contact, erythema, rash, urticaria (1% each)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 97 at risk

Adverse event: Contusion, fall, joint sprain, procedural dizziness/pain, thermal pain (1% each)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 97 at risk

Adverse event: Cough, nasal/sinus congestion (1% each)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Insomnia, libido increased, restlessness (1% each)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hypersensitivity, seasonal allergy (1% each)
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 97 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 100 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 100 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 100 at risk

Adverse event: Injection/vessel puncture site hematoma (1% each)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 100 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 100 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 100 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 100 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 100 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 100 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 100 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Abdominal pain/discomfort, lower/upper abdominal pain, dyspepsia (1% each)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Feeling hot/jittery, inj site reac/hemorrhage/rash, pain, chest pain (1% each)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: Fungal infect, gastroenter/bronchitis, vulvo/vaginitis, follicul/pharyngitis, tooth abcess (1% each)
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 100 at risk

Adverse event: Migraine, sciatica, sinus headache (1% each)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 100 at risk

Adverse event: Hematoma, hot flush (1% each)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 100 at risk

Adverse event: Musculoskeletal pain/myalgia, arthralgia, muscle spasms, flank pain (1% each)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 100 at risk

Adverse event: Vag hemorrh/discharge, breast tend/mass, metrorrhagia, menstru irreg, genit discomfort/order (1% ea)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 100 at risk

Adverse event: CPK/glu/lipase/chol/BP/triglycerides increased, iron decreased, MCV abnormal (1% each)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 100 at risk

Adverse event: Acne, pruritis, dermatitis contact, erythema, rash, urticaria (1% each)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 100 at risk

Adverse event: Contusion, fall, joint sprain, procedural dizziness/pain, thermal pain (1% each)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Cough, nasal/sinus congestion (1% each)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Insomnia, libido increased, restlessness (1% each)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypersensitivity, seasonal allergy (1% each)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 100 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 100 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 99 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 99 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 99 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 99 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 99 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 99 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 99 at risk

Adverse event: Injection/vessel puncture site hematoma (1% each)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 99 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 99 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 99 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 99 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 99 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 99 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 99 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 99 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 99 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 99 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Abdominal pain/discomfort, lower/upper abdominal pain, dyspepsia (1% each)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 99 at risk

Adverse event: Feeling hot/jittery, inj site reac/hemorrhage/rash, pain, chest pain (1% each)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Fungal infect, gastroenter/bronchitis, vulvo/vaginitis, follicul/pharyngitis, tooth abcess (1% each)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 99 at risk

Adverse event: Migraine, sciatica, sinus headache (1% each)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 99 at risk

Adverse event: Hematoma, hot flush (1% each)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 99 at risk

Adverse event: Musculoskeletal pain/myalgia, arthralgia, muscle spasms, flank pain (1% each)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 99 at risk

Adverse event: Vag hemorrh/discharge, breast tend/mass, metrorrhagia, menstru irreg, genit discomfort/order (1% ea)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 99 at risk

Adverse event: CPK/glu/lipase/chol/BP/triglycerides increased, iron decreased, MCV abnormal (1% each)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 99 at risk

Adverse event: Acne, pruritis, dermatitis contact, erythema, rash, urticaria (1% each)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 99 at risk

Adverse event: Contusion, fall, joint sprain, procedural dizziness/pain, thermal pain (1% each)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 99 at risk

Adverse event: Cough, nasal/sinus congestion (1% each)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 99 at risk

Adverse event: Insomnia, libido increased, restlessness (1% each)
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 99 at risk

Adverse event: Hypersensitivity, seasonal allergy (1% each)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 99 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 98 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 6 affected / 98 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 98 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 98 at risk

Adverse event: Injection/vessel puncture site hematoma (1% each)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 98 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 98 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 98 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 98 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 98 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 98 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 98 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 98 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 98 at risk

Adverse event: Abdominal pain/discomfort, lower/upper abdominal pain, dyspepsia (1% each)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 98 at risk

Adverse event: Feeling hot/jittery, inj site reac/hemorrhage/rash, pain, chest pain (1% each)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 98 at risk

Adverse event: Fungal infect, gastroenter/bronchitis, vulvo/vaginitis, follicul/pharyngitis, tooth abcess (1% each)
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 98 at risk

Adverse event: Migraine, sciatica, sinus headache (1% each)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 98 at risk

Adverse event: Hematoma, hot flush (1% each)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 98 at risk

Adverse event: Musculoskeletal pain/myalgia, arthralgia, muscle spasms, flank pain (1% each)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 98 at risk

Adverse event: Vag hemorrh/discharge, breast tend/mass, metrorrhagia, menstru irreg, genit discomfort/order (1% ea)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 98 at risk

Adverse event: CPK/glu/lipase/chol/BP/triglycerides increased, iron decreased, MCV abnormal (1% each)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 98 at risk

Adverse event: Acne, pruritis, dermatitis contact, erythema, rash, urticaria (1% each)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 98 at risk

Adverse event: Contusion, fall, joint sprain, procedural dizziness/pain, thermal pain (1% each)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 98 at risk

Adverse event: Cough, nasal/sinus congestion (1% each)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: Insomnia, libido increased, restlessness (1% each)
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 98 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 98 at risk