39 lines
14 KiB
Markdown
39 lines
14 KiB
Markdown
to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data) for VTEp, NVAF, and VTEt respectively.
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Table 2: Tabulated adverse reactions
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| System organ class | Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery (VTEp) | Prevention of stroke and systemic embolism in adult patients with NVAF, with one or more risk factors (NVAF) | Treatment of DVT and PE, and prevention of recurrent DVT and PE (VTEt) |
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| ---------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------- |
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| Blood and lymphatic system disorders | | | |
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| Anaemia | Common | Common | Common |
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| Thrombocytopenia | Uncommon | Uncommon | Common |
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| Immune system disorders | | | |
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| Hypersensitivity, allergic oedema and Anaphylaxis | Rare | Uncommon | Uncommon |
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| Pruritus | Uncommon | Uncommon | Uncommon\* |
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| Angioedema | Not known | Not known | Not known |
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| Nervous system disorders | | | |
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| Brain haemorrhage † | Not known | Uncommon | Rare |
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| Eye disorders | | | |
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| Eye haemorrhage (including conjunctival haemorrhage) | Rare | Common | Uncommon |
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| Vascular disorders | | | |
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| Haemorrhage, haematoma | Common | Common | Common |
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| Hypotension (including procedural hypotension) | Uncommon | Common | Uncommon |
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| Intra-abdominal haemorrhage | Not known | Uncommon | Not known |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | | |
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| Epistaxis | Uncommon | Common | Common |
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| Haemoptysis | Rare | Uncommon | Uncommon |
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| Respiratory tract haemorrhage | Not known | Rare | Rare |
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| Gastrointestinal disorders | | | |
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| Nausea | Common | Common | Common |
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| Gastrointestinal haemorrhage | Uncommon | Common | Common |
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| Haemorrhoidal haemorrhage | Not known | Uncommon | Uncommon |
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| Mouth haemorrhage | Not known | Uncommon | Common |
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| Haematochezia | Uncommon | Uncommon | Uncommon |
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| Rectal haemorrhage, gingival bleeding | Rare | Common | Common |
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| Retroperitoneal haemorrhage | Not known | Rare | Not known |
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| Hepatobiliary disorders | | | |
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| Liver function test abnormal, asparate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased | Uncommon | Uncommon | Uncommon |
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| Gamma-glutamyltransferase increased | Uncommon | Common | Common |
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| Alanine aminotransferase increased | Uncommon | Uncommon | Common |
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| Skin and subcutaneous tissue disorders | | | |
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