TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00535496

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 29 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 29 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 29 at risk

Adverse event: Underdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 29 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Perforation bile duct
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 61 at risk

Adverse event: Procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 61 at risk

Adverse event: Bladder disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 61 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 61 at risk

Adverse event: Rash erythematous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 61 at risk

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 61 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 61 at risk

Adverse event: Procedural hypertension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 61 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 61 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 31 affected / 61 at risk
Study: NCT00535626

Adverse event: Operative site
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 193 at risk

Adverse event: Operative site
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 193 at risk

Adverse event: Operative site
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 193 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 190 at risk

Adverse event: Non-operative site
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 190 at risk
Study: NCT00535652

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 20 at risk
Study: NCT00535925

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 44 affected / 188 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 188 at risk

Adverse event: revascularization
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 188 at risk

Adverse event: major amputation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 188 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: if fasting glycemia \<= 70 mg/dL
Frequency: 1 affected / 188 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Notes: if systolic blood pressure \<= 100 mmHg
Frequency: 2 affected / 188 at risk

Adverse event: End stage renal disease
Serious: no
Organ System: Renal and urinary disorders
Notes: if eGFR (CKD-EPI) \< 15 ml/min
Frequency: 2 affected / 188 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 207 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 207 at risk

Adverse event: revascularization
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 207 at risk

Adverse event: major amputation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 207 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: if fasting glycemia \<= 70 mg/dL
Frequency: 3 affected / 207 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Notes: if systolic blood pressure \<= 100 mmHg
Frequency: 2 affected / 207 at risk

Adverse event: End stage renal disease
Serious: no
Organ System: Renal and urinary disorders
Notes: if eGFR (CKD-EPI) \< 15 ml/min
Frequency: 3 affected / 207 at risk
Study: NCT00536198

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 125 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 125 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 125 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 125 at risk

Adverse event: Mouth Dryness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 125 at risk

Adverse event: Difficulty Concentrating
Serious: no
Organ System: General disorders
Frequency: 9 affected / 125 at risk

Adverse event: Anxiety, Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 125 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 10 affected / 125 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 125 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 127 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 127 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 127 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 127 at risk

Adverse event: Mouth Dryness
Serious: no
Organ System: General disorders
Frequency: 13 affected / 127 at risk

Adverse event: Difficulty Concentrating
Serious: no
Organ System: General disorders
Frequency: 8 affected / 127 at risk

Adverse event: Anxiety, Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 127 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 127 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 127 at risk
Study: NCT00536380

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 106 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 104 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 104 at risk
Study: NCT00536510

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 321 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 321 at risk

Adverse event: Gastritis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 321 at risk

Adverse event: Periarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 321 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 321 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 321 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 321 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 321 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 321 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 298 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Endocrine disorders
Frequency: 12 affected / 299 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: General disorders
Frequency: 9 affected / 281 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 323 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 323 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 323 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 323 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 323 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 323 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 323 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 310 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 310 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: General disorders
Frequency: 7 affected / 302 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk
Study: NCT00536601

Adverse event: Regimen Related Toxicity
Serious: yes
Organ System: General disorders
Notes: Any organ system (cardiac, renal, pulmonary, lower GI, CNS, hepatic, stomatitis, bladder)
Frequency: 1 affected / 6 at risk

Adverse event: Regimen Related Toxicity
Serious: yes
Organ System: General disorders
Notes: Any organ system (cardiac, renal, pulmonary, lower GI, CNS, hepatic, stomatitis, bladder)
Frequency: 9 affected / 21 at risk

Adverse event: Regimen Related Toxicity
Serious: yes
Organ System: General disorders
Notes: Any organ system (cardiac, renal, pulmonary, lower GI, CNS, hepatic, stomatitis, bladder)
Frequency: 19 affected / 71 at risk

Adverse event: Regimen Related Toxicity
Serious: yes
Organ System: General disorders
Notes: Any organ system (cardiac, renal, pulmonary, lower GI, CNS, hepatic, stomatitis, bladder)
Frequency: 31 affected / 65 at risk

Adverse event: Regimen Related Toxicity
Serious: yes
Organ System: General disorders
Notes: Any organ system (cardiac, renal, pulmonary, lower GI, CNS, hepatic, stomatitis, bladder)
Frequency: 3 affected / 11 at risk
Study: NCT00536731

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 246 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 243 at risk
Study: NCT00536939

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Musculoskeletal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk
Study: NCT00536978

Adverse event: Neutrophils (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Absolute neutrophil count (ANC)/Absolute granulocyte count (AGC)
Frequency: 1 affected / 22 at risk

Adverse event: Acute respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Fever, Neutropenic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Mood Alteration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pain, Chest Wall
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Graft versus host disease (GVHD), Chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Infection, Neutropenic (other)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk
Study: NCT00537134

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 42 at risk

Adverse event: arm hematoma
Serious: no
Organ System: Surgical and medical procedures
Notes: hematoma resulting from arm arterial line complication
Frequency: 1 affected / 42 at risk
Study: NCT00537277

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Toxic nodular goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 160 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 160 at risk

Adverse event: Asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 160 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 160 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 160 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 160 at risk
Study: NCT00537576

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: expected AE
Frequency: 1 affected / 3 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vaginal odour
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: expected AE
Frequency: 2 affected / 3 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vaginal odour
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: expected AE
Frequency: 2 affected / 3 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3 at risk

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

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

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

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

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

Adverse event: Vulvovaginitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1 at risk
Study: NCT00537680

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 22 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 22 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 22 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 10 affected / 22 at risk

Adverse event: Musculoskeletal & connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 22 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 24 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 24 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 24 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 9 affected / 24 at risk

Adverse event: Musculoskeletal & connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 24 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 24 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 24 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 24 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 9 affected / 24 at risk

Adverse event: Musculoskeletal & connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 24 at risk
Study: NCT00537745

Adverse event: Induration at Injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Induration at injection site. The area of induration at the injection site gradually subsided and was not palpable at the end of the study.
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk