MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
Haemorrhage
|
Haemorrhage
|
common, 1.13% - 1.37%
|
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
common, 1.13% - 1.37%
|
|
x
|
x
|
Anaemia
|
Anaemia
|
common, 2.58% - 3.01%
|
|
x
|
x
|
Epistaxis
|
Epistaxis
|
uncommon — 1.55% - 3.58%
|
1.09%
|
x
|
x
|
Haemorrhagic anaemia
|
Haemorrhagic anaemia
|
2.58% - 3.01%
|
|
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
uncommon, common
|
|
x
|
x
|
Haematemesis
|
Haematemesis
|
uncommon, common
|
|
x
|
x
|
Melaena
|
Melaena
|
uncommon, common
|
|
x
|
x
|
Nausea
|
Nausea
|
common, 2.58% - 2.69%
|
|
x
|
x
|
Conjunctival haemorrhage
|
Conjunctival haemorrhage
|
rare, common
|
|
x
|
x
|
Eye haemorrhage
|
Eye haemorrhage
|
rare, common
|
|
x
|
x
|
Contusion
|
Contusion
|
common, 1.4% - 2.22%
|
2.18%
|
x
|
x
|
Haematuria
|
Haematuria
|
uncommon — 1.43% - 2.1%
|
1.09%
|
x
|
x
|
Blood urine
|
|
|
|
x
|
Haematoma
|
Haematoma
|
common, 1.13% - 1.97%
|
1.21%
|
x
|
x
|
Menorrhagia
|
Menorrhagia
|
1.42%
|
|
|
x
|
Urethral haemorrhage
|
Urethral haemorrhage
|
common, 1.13% - 1.37%
|
|
x
|
x
|
Gingival bleeding
|
Gingival bleeding
|
rare — 0.972% - 1.43%
|
0.363%
|
x
|
x
|
Rectal haemorrhage
|
Rectal haemorrhage
|
rare — 0.972%
|
|
x
|
x
|
Wound haemorrhage
|
Wound haemorrhage
|
uncommon, 0.912% - 1.02%
|
|
x
|
x
|
Catheter site haemorrhage
|
Catheter site haemorrhage
|
uncommon, 0.912% - 1.02%
|
|
x
|
x
|
Post procedural haematoma
|
Post procedural haematoma
|
uncommon, 0.912% - 1.02%
|
|
x
|
x
|
Vessel puncture site haematoma
|
Vessel puncture site haematoma
|
uncommon, 0.912% - 1.02%
|
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
uncommon, 0.844% - 1.2%
|
|
x
|
x
|
Transaminases increased
|
Transaminases increased
|
uncommon, 0.844% - 1.2%
|
|
x
|
x
|
Alanine aminotransferase abnormal
|
Alanine aminotransferase abnormal
|
uncommon, 0.844% - 1.2%
|
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
uncommon, 0.793% - 1.17%
|
|
x
|
x
|
Post procedural haemorrhage
|
Post procedural haemorrhage
|
uncommon, 0.912% - 1.02%
|
|
x
|
x
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
uncommon, 0.641% - 1.1%
|
|
x
|
x
|
Haemoptysis
|
Haemoptysis
|
rare, 1.2%
|
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
uncommon
|
|
x
|
x
|
Dermatitis
|
Rash
|
uncommon
|
|
x
|
x
|
Rash
|
Rash
|
uncommon
|
|
x
|
x
|
Haematochezia
|
Haematochezia
|
uncommon
|
|
x
|
x
|
Subdural haematoma
|
Subdural haematoma
|
uncommon
|
|
x
|
|
Hypotension
|
Hypotension
|
uncommon
|
|
x
|
x
|
Mouth haemorrhage
|
Mouth haemorrhage
|
uncommon
|
|
x
|
|
Subarachnoid haemorrhage
|
Subarachnoid haemorrhage
|
uncommon
|
|
x
|
|
Thrombocytopenia
|
Thrombocytopenia
|
uncommon
|
|
x
|
x
|
Traumatic haemorrhage
|
Traumatic haemorrhage
|
uncommon
|
|
x
|
|
Procedural haemorrhage
|
Intraoperative hemorrhage
|
uncommon
|
|
x
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
uncommon
|
|
x
|
x
|
Intra-abdominal haemorrhage
|
Intra-abdominal haemorrhage
|
uncommon
|
|
x
|
|
Haemorrhoidal haemorrhage
|
Haemorrhoidal haemorrhage
|
uncommon
|
|
x
|
x
|
Blood bilirubin increased
|
Blood bilirubin increased
|
uncommon
|
|
x
|
x
|
Wound secretion
|
Wound secretion
|
uncommon
|
|
x
|
x
|
Allergic oedema
|
Allergic oedema
|
uncommon
|
|
x
|
x
|
Blood alkaline phosphatase increased
|
Blood alkaline phosphatase increased
|
uncommon
|
|
x
|
x
|
Spinal haematoma
|
Spinal haematoma
|
uncommon
|
|
x
|
|
Occult blood positive
|
Occult blood positive
|
uncommon
|
|
x
|
x
|
Application site haemorrhage
|
Application site haemorrhage
|
uncommon
|
|
x
|
|
Urogenital haemorrhage
|
Urogenital haemorrhage
|
uncommon
|
|
x
|
|
Incision site haemorrhage
|
Incision site haemorrhage
|
uncommon
|
|
x
|
x
|
Incision site haematoma
|
Incision site haematoma
|
uncommon
|
|
x
|
x
|
Procedural hypotension
|
Procedural hypotension
|
uncommon
|
|
x
|
x
|
Cerebral haemorrhage
|
Cerebral haemorrhage
|
uncommon
|
|
x
|
|
Haemorrhagic stroke
|
|
|
|
x
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
uncommon
|
|
x
|
x
|
Spinal cord haemorrhage
|
Intraspinal bleeding
|
uncommon
|
|
x
|
|
Hypersensitivity
|
Hypersensitivity
|
rare, uncommon
|
|
x
|
x
|
Muscle haemorrhage
|
Muscle haemorrhage
|
rare
|
|
x
|
x
|
Retroperitoneal haemorrhage
|
Retroperitoneal haemorrhage
|
rare
|
|
x
|
|
Respiratory tract haemorrhage
|
Respiratory tract haemorrhage
|
rare
|
|
x
|
|
Pharyngeal haemorrhage
|
Pharyngeal haemorrhage
|
rare
|
|
x
|
|
Pulmonary alveolar haemorrhage
|
Pulmonary alveolar haemorrhage
|
rare
|
|
x
|
|
Laryngeal haemorrhage
|
Laryngeal haemorrhage
|
rare
|
|
x
|
|
Breast disorder
|
Breast disorder
|
|
|
x
|
x
|
Compartment syndrome
|
Compartment syndrome
|
|
|
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
x
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
|
|
|
x
|
Drug hypersensitivity
|
Drug hypersensitivity
|
|
|
|
x
|
Ecchymosis
|
Ecchymosis
|
|
|
|
x
|
Eye disorder
|
Eye disorder
|
|
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
|
|
x
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
x
|
x
|
Metrorrhagia
|
Metrorrhagia
|
|
|
|
x
|
Nervous system disorder
|
Nervous system disorder
|
|
|
x
|
|
Petechiae
|
Petechiae
|
|
|
|
x
|
Retinal haemorrhage
|
Retinal haemorrhage
|
|
|
|
x
|
Dizziness
|
Syncope
|
|
|
|
x
|
Shock
|
Syncope
|
|
|
|
x
|
Syncope
|
Syncope
|
|
|
|
x
|
Loss of consciousness
|
Syncope
|
|
|
|
x
|
Urethral disorder
|
Urinary tract disorder
|
|
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
x
|
x
|
Angiopathy
|
Angiopathy
|
|
|
x
|
x
|
Haemorrhage intracranial
|
Haemorrhage intracranial
|
|
|
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
x
|
Blood urine
|
Blood urine
|
|
|
|
x
|
Blood urine present
|
Blood urine
|
|
|
|
x
|
Blood urine present
|
|
|
|
x
|
Menometrorrhagia
|
Menometrorrhagia
|
|
|
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
x
|
x
|
Anal haemorrhage
|
Anal haemorrhage
|
|
|
|
x
|
Periorbital haematoma
|
Periorbital haematoma
|
|
|
|
x
|
Injection site haematoma
|
Injection site haematoma
|
|
|
|
x
|
Traumatic haematoma
|
Traumatic haematoma
|
|
|
|
x
|
Haemorrhagic stroke
|
Haemorrhagic stroke
|
|
|
|
x
|
Skin haemorrhage
|
Skin haemorrhage
|
|
|
|
x
|
Genital haemorrhage
|
Genital haemorrhage
|
|
|
|
x
|