Trial Outcomes & Findings for Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis (NCT NCT00277394)

NCT ID: NCT00277394

Last Updated: 2025-03-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 541 participants
• Primary outcome timeframe: prior to day 90 +/- 5
• Results posted on: 2025-03-06

Participant Flow

Recruitment took place between Dec 2005 and May 2008

2 patients were not randomized

Participant milestones

Measure	Innohep® innohep® 175 anti-Xa IU/kg once daily	Heparin Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
Overall Study STARTED	269	270
Overall Study COMPLETED	232	246
Overall Study NOT COMPLETED	37	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis

Baseline characteristics by cohort

Measure	Innohep® n=269 Participants innohep® 175 anti-Xa IU/kg once daily	Heparin n=270 Participants Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.	Total n=539 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	269 Participants n=5 Participants	270 Participants n=7 Participants	539 Participants n=5 Participants
Age, Continuous	82.9 years STANDARD_DEVIATION 5.7 • n=5 Participants	82.6 years STANDARD_DEVIATION 5.8 • n=7 Participants	82.8 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	177 Participants n=5 Participants	168 Participants n=7 Participants	345 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	102 Participants n=7 Participants	194 Participants n=5 Participants
Region of Enrollment Serbia	37 participants n=5 Participants	43 participants n=7 Participants	80 participants n=5 Participants
Region of Enrollment France	139 participants n=5 Participants	139 participants n=7 Participants	278 participants n=5 Participants
Region of Enrollment Poland	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Spain	39 participants n=5 Participants	38 participants n=7 Participants	77 participants n=5 Participants
Region of Enrollment Romania	30 participants n=5 Participants	20 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment Croatia	9 participants n=5 Participants	16 participants n=7 Participants	25 participants n=5 Participants
Region of Enrollment Germany	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Belgium	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: prior to day 90 +/- 5

Population: 2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses

Outcome measures

Measure	Innohep® n=269 Participants innohep® 175 anti-Xa IU/kg once daily	Heparin n=268 Participants Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
Number of Patients With Clinically Relevant Bleeding Events	32 Patients	32 Patients

SECONDARY outcome

Timeframe: prior to day 90 +/- 5

Population: 2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses

Outcome measures

Measure	Innohep® n=269 Participants innohep® 175 anti-Xa IU/kg once daily	Heparin n=268 Participants Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
Number of Patients With Recurrence of Venous Thromboembolism	16 Patients	9 Patients

SECONDARY outcome

Timeframe: prior to day 90 +/- 5

Population: 2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses

Outcome measures

Measure	Innohep® n=269 Participants innohep® 175 anti-Xa IU/kg once daily	Heparin n=268 Participants Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
Number of Patients With Major Bleeding Events	12 Patients	10 Patients

Adverse Events

Innohep®

Serious events: 63 serious events

Other events: 66 other events

Deaths: 0 deaths

Heparin

Serious events: 52 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Measure	Innohep® n=270 participants at risk innohep® 175 anti-Xa IU/kg once daily	Heparin n=264 participants at risk Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Cerebral haematoma	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Cerebrovascular accident	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Cognitive disorder	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Cubital tunnel syndrome	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Dementia	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Haemorrhagic stroke	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Headache	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Ischaemic stroke	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Loss of consciousness	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Nervous system disorders Somnolence	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Psychiatric disorders Depression	1.1% 3/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Renal and urinary disorders Haematuria	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Renal and urinary disorders Renal failure acute	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Renal and urinary disorders Urethral haemorrhage	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Renal and urinary disorders Urinary retention	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Reproductive system and breast disorders Ovarian cyst	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Chronic obstructive airways disease exacerbated	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Dependence on respirator	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 3/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 3/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Surgical and medical procedures Amputation	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Surgical and medical procedures Anticoagulant therapy	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Surgical and medical procedures Pneumatic compression therapy	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Surgical and medical procedures Surgery	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Arterial occlusive disease	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Investigations Biopsy liver	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Investigations Coagulation time prolonged	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Investigations Haemoglobin decreased	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Investigations International normalised ratio increased	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Investigations Prostatic specific antigen increased	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Investigations Sigmoidoscopy	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Metabolism and nutrition disorders Cachexia	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Metabolism and nutrition disorders Dehydration	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Metabolism and nutrition disorders Metabolic acidosis	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Musculoskeletal and connective tissue disorders Intervertebral discitis	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Musculoskeletal and connective tissue disorders Spondylolisthesis acquired	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Musculoskeletal and connective tissue disorders Synovitis	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Blood and lymphatic system disorders Anaemia	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	1.1% 3/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Blood and lymphatic system disorders Iron deficiency anaemia	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Cardiac disorders Arrhythmia	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Cardiac disorders Atrial fibrillation	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Cardiac disorders Atrioventricular block	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Cardiac disorders Bradycardia	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Cardiac disorders Cardiac arrest	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Cardiac disorders Cardiac failure	2.2% 6/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	2.3% 6/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Cardiac disorders Cardiopulmonary failure	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Cardiac disorders Conduction disorder	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Cardiac disorders Left ventricular failure	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Ear and labyrinth disorders Otorrhoea	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Endocrine disorders Thyrotoxicosis	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Abdominal distension	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Abdominal pain	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Colitis	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Diarrhoea	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Duodenitis	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Gastric haemorrhage	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Haematemesis	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Melaena	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Nausea	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Oesophageal ulcer	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Peritoneal haemorrhage	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Rectal haemorrhage	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Subileus	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Vomiting	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
General disorders Death	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
General disorders General physical health deterioration	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
General disorders Heparin-induced thrombocytopenia	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
General disorders Inflammation	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
General disorders Malaise	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
General disorders Multi-organ failure	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
General disorders Sudden death	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
General disorders Terminal state	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Abdominal abscess	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Cellulitis	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Erysipelas	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Gastrointestinal infection	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Haematoma infection	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Hepatitis B	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Parotitis	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Pneumonia escherichia	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Sepsis	1.5% 4/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Sepsis secondary	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Septic shock	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Urinary tract infection	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Wound infection	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Injury, poisoning and procedural complications Fall	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Injury, poisoning and procedural complications Femur fracture	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Injury, poisoning and procedural complications Fracture	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Injury, poisoning and procedural complications Fractured sacrum	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Injury, poisoning and procedural complications Injury	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.74% 2/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Deep vein thrombosis	1.9% 5/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Embolism	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Extremity necrosis	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Haematoma	1.9% 5/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	1.1% 3/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Ischaemia	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Peripheral ischaemia	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Phlebothrombosis	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Post thrombotic syndrome	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.00% 0/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Vasculitis	0.00% 0/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.38% 1/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Pneumonia	0.37% 1/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	0.76% 2/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.

Other adverse events

Measure	Innohep® n=270 participants at risk innohep® 175 anti-Xa IU/kg once daily	Heparin n=264 participants at risk Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
Gastrointestinal disorders Constipation	6.3% 17/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	8.7% 23/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Gastrointestinal disorders Diarrhoea	4.4% 12/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	5.7% 15/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Infections and infestations Urinary tract infection	9.3% 25/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	6.1% 16/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 10/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	5.3% 14/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.
Vascular disorders Haematoma	7.8% 21/270 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.	7.6% 20/264 Five patients who did not receive any study treatment were excluded from the safety analysis set. Three patients randomised to the Heparin group received innohe® during all their SC treatment period by mistake. These three patients were accounted for with respect to the trial medication actually taken, i.e. innohep®, in the safety analysis set.

Additional Information

Torsten Skov, Senior Medical Advisor

Leo Pharma

Phone: +45 72263990

Email: tosdk@leo-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60