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.

Table 2: Tabulated adverse reactions

| 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) |
| ---------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------- |
| Blood and lymphatic system disorders                                                                                               |                                                                                                        |                                                                                                              |                                                                        |
| Anaemia                                                                                                                            | Common                                                                                                 | Common                                                                                                       | Common                                                                 |
| Thrombocytopenia                                                                                                                   | Uncommon                                                                                               | Uncommon                                                                                                     | Common                                                                 |
| Immune system disorders                                                                                                            |                                                                                                        |                                                                                                              |                                                                        |
| Hypersensitivity, allergic oedema and Anaphylaxis                                                                                  | Rare                                                                                                   | Uncommon                                                                                                     | Uncommon                                                               |
| Pruritus                                                                                                                           | Uncommon                                                                                               | Uncommon                                                                                                     | Uncommon\*                                                             |
| Angioedema                                                                                                                         | Not known                                                                                              | Not known                                                                                                    | Not known                                                              |
| Nervous system disorders                                                                                                           |                                                                                                        |                                                                                                              |                                                                        |
| Brain haemorrhage †                                                                                                                | Not known                                                                                              | Uncommon                                                                                                     | Rare                                                                   |
| Eye disorders                                                                                                                      |                                                                                                        |                                                                                                              |                                                                        |
| Eye haemorrhage (including conjunctival haemorrhage)                                                                               | Rare                                                                                                   | Common                                                                                                       | Uncommon                                                               |
| Vascular disorders                                                                                                                 |                                                                                                        |                                                                                                              |                                                                        |
| Haemorrhage, haematoma                                                                                                             | Common                                                                                                 | Common                                                                                                       | Common                                                                 |
| Hypotension (including procedural hypotension)                                                                                     | Uncommon                                                                                               | Common                                                                                                       | Uncommon                                                               |
| Intra-abdominal haemorrhage                                                                                                        | Not known                                                                                              | Uncommon                                                                                                     | Not known                                                              |
| Respiratory, thoracic and mediastinal disorders                                                                                    | Respiratory, thoracic and mediastinal disorders                                                        |                                                                                                              |                                                                        |
| Epistaxis                                                                                                                          | Uncommon                                                                                               | Common                                                                                                       | Common                                                                 |
| Haemoptysis                                                                                                                        | Rare                                                                                                   | Uncommon                                                                                                     | Uncommon                                                               |
| Respiratory tract haemorrhage                                                                                                      | Not known                                                                                              | Rare                                                                                                         | Rare                                                                   |
| Gastrointestinal disorders                                                                                                         |                                                                                                        |                                                                                                              |                                                                        |
| Nausea                                                                                                                             | Common                                                                                                 | Common                                                                                                       | Common                                                                 |
| Gastrointestinal haemorrhage                                                                                                       | Uncommon                                                                                               | Common                                                                                                       | Common                                                                 |
| Haemorrhoidal haemorrhage                                                                                                          | Not known                                                                                              | Uncommon                                                                                                     | Uncommon                                                               |
| Mouth haemorrhage                                                                                                                  | Not known                                                                                              | Uncommon                                                                                                     | Common                                                                 |
| Haematochezia                                                                                                                      | Uncommon                                                                                               | Uncommon                                                                                                     | Uncommon                                                               |
| Rectal haemorrhage, gingival bleeding                                                                                              | Rare                                                                                                   | Common                                                                                                       | Common                                                                 |
| Retroperitoneal haemorrhage                                                                                                        | Not known                                                                                              | Rare                                                                                                         | Not known                                                              |
| Hepatobiliary disorders                                                                                                            |                                                                                                        |                                                                                                              |                                                                        |
| Liver function test abnormal, asparate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased | Uncommon                                                                                               | Uncommon                                                                                                     | Uncommon                                                               |
| Gamma-glutamyltransferase increased                                                                                                | Uncommon                                                                                               | Common                                                                                                       | Common                                                                 |
| Alanine aminotransferase increased                                                                                                 | Uncommon                                                                                               | Uncommon                                                                                                     | Common                                                                 |
| Skin and subcutaneous tissue disorders                                                                                             |                                                                                                        |                                                                                                              |                                                                        |