TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01001546

Adverse event: Hospitalization - mental health
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hospitalization - respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 206 at risk

Adverse event: Hospitalization - cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 206 at risk

Adverse event: Hospitalization - knee surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 206 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 206 at risk

Adverse event: Adverse reaction to Nicotine Replacement Medication (NRT)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 206 at risk

Adverse event: Adverse reaction to Nicotine Replacement Medication (NRT)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Adverse reaction to Nicotine Replacement Medication (NRT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 206 at risk

Adverse event: Minor Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 206 at risk

Adverse event: Hospitalization - mental health
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 207 at risk

Adverse event: Hospitalization - knee surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 207 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 207 at risk

Adverse event: Adverse reaction to Nicotine Replacement Medication (NRT)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Social circumstances
Notes: Not seriously injured
Frequency: 2 affected / 207 at risk

Adverse event: Pregnancy/Childbirth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 207 at risk

Adverse event: Minor Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 207 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 207 at risk
Study: NCT01001559

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Limited information regarding SAEs is available. Four hospitalizations, among three subjects in the Antidepressant Alone arm, and one hospitalization in the Deplin + Antidepressant arm occurred. No information regarding AE term or SOC is available.
Frequency: 1 affected / 93 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 93 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 93 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 93 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 93 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 93 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 93 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 93 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 93 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 93 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Limited information regarding SAEs is available. Four hospitalizations, among three subjects in the Antidepressant Alone arm, and one hospitalization in the Deplin + Antidepressant arm occurred. No information regarding AE term or SOC is available.
Frequency: 3 affected / 103 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 103 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 103 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 103 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 103 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 103 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 103 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 103 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 103 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 103 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk
Study: NCT01001572

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 325 at risk
Study: NCT01001598

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Danazol started at 5 mg/kg/day (200 mg/day); day 9 a rash that on her hands and spread to the rest of her body diagnosed as hives. Also on birth control (Altavera). Dermatologist at BCH recommended against re-starting the danazol.
Frequency: 1 affected / 5 at risk

Adverse event: Mood changes
Serious: no
Organ System: Nervous system disorders
Notes: Probably related
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Notes: Enlargement of the left lobe
Frequency: 1 affected / 5 at risk

Adverse event: Virilism
Serious: no
Organ System: Endocrine disorders
Notes: Clitoral and phallic enlargement
Frequency: 2 affected / 5 at risk
Study: NCT01001702

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 85 at risk

Adverse event: Psychomotor hyperactivity
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 85 at risk

Adverse event: Impulsive behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 85 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 85 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 85 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 85 at risk

Adverse event: Social stay hospitalisation
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 85 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 85 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 85 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 85 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 85 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 85 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 85 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 85 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 85 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 85 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 85 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 85 at risk
Study: NCT01001910

Adverse event: Hematologic
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Neutropenia or Thrombocytopenia or Anemia
Frequency: 8 affected / 22 at risk

Adverse event: Non-Hematologic
Serious: yes
Organ System: General disorders
Notes: Elevated LFTs or Abdominal pain or Hypomagnesemia or Hyperglycemia or Hypersensitivity or Chest pain or Temporal parietal hemotoma or Bell's palsy
Frequency: 3 affected / 22 at risk
Study: NCT01002287

Adverse event: Fasciitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Impaired healing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Surgical skin tear
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk
Study: NCT01002482

Adverse event: BG of 40 mg per deciliter or less accompanied with observed or suspected neurological symptoms
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 1336 at risk

Adverse event: BG of 40 mg per deciliter or less accompanied with observed or suspected neurological symptoms
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 1312 at risk
Study: NCT01002742

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 119 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 119 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 119 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Fistula
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 119 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 119 at risk

Adverse event: Vertebroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 119 at risk

Adverse event: Thrombotic thrombocytopenic purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 116 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Cerebellar ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: Lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 116 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 116 at risk
Study: NCT01002820

Adverse event: Tension headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dermatophytosis of nail
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Focal dyscognitive seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Intracranial aneurysm
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Menometrorrhagia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Aortic aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk
Study: NCT01002872

Adverse event: mild
Serious: no
Organ System: General disorders
Notes: Broken tooth
Frequency: 1 affected / 10 at risk
Study: NCT01003067

Adverse event: Bowel Fistulation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 131 at risk
Study: NCT01003210

Adverse event: vomit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 104 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 104 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 104 at risk

Adverse event: "hyper" behavior
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 104 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 15 affected / 104 at risk

Adverse event: Others
Serious: no
Organ System: General disorders
Frequency: 14 affected / 104 at risk

Adverse event: decreased hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 104 at risk

Adverse event: ear plugging
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 104 at risk

Adverse event: ears popping
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 104 at risk

Adverse event: redness around ear
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: vomit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 102 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 102 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 102 at risk

Adverse event: "hyper" behavior
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 102 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 23 affected / 102 at risk

Adverse event: Others
Serious: no
Organ System: General disorders
Frequency: 23 affected / 102 at risk
Study: NCT01003249

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: flare up in psychosis history of subject
Frequency: 1 affected / 12 at risk

Adverse event: GI Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Common GI symptoms: bloating, upset stomach, nausea, etc..All GI Symptoms were collected/recorded under a single adverse event term
Frequency: 1 affected / 12 at risk

Adverse event: Excessive Sleepiness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Feeling too loose
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: GI Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Common GI symptoms: bloating, upset stomach, nausea, etc..All GI Symptoms were collected/recorded under a single adverse event term
Frequency: 1 affected / 12 at risk

Adverse event: Excessive Sleepiness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Feeling too loose
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 12 at risk
Study: NCT01003275

Adverse event: Hypercalcaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 22 at risk

Adverse event: Elevated serum creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Fistula placement
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Renal artery stent
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dyspnea with palpitations and lightheadedness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Elevated blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Elevated blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Paresthesias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 21 at risk

Adverse event: Allergies
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Cataract surgery
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Skin cancer removal
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 21 at risk
Study: NCT01003288

Adverse event: pain at injection site
Serious: no
Organ System: Infections and infestations
Frequency: 196 affected / 255 at risk