Trial Outcomes & Findings for The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086) (NCT NCT00765063)

NCT ID: NCT00765063

Last Updated: 2012-01-13

Results Overview

Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline to Week 24 (EOT) or ET
• Results posted on: 2012-01-13

Participant Flow

This was a follow-up study of A6301083 (NCT00662831)

Participant milestones

Measure	Dalteparin Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Study STARTED	62
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Measure	Dalteparin Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Study Lack of Efficacy	5
Overall Study Withdrawal by Subject	1
Overall Study Other	16
Overall Study Protocol Violation	6
Overall Study Adverse Event	4

Baseline Characteristics

The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

Baseline characteristics by cohort

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Age Continuous	65.2 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)

Population: Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.

Outcome measures

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Number of All Hemorrhages	3 Hemorrhages

PRIMARY outcome

Timeframe: Baseline to Week 24 (EOT) or ET

Population: Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular).

Outcome measures

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Number of Major Hemorrhages	0 Hemorrhages

PRIMARY outcome

Timeframe: Baseline to Week 24 (EOT) or ET

Population: Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.

Outcome measures

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Number of Minor Hemorrhages	3 Hemorrhages

PRIMARY outcome

Timeframe: Baseline to Week 24 (EOT) or ET

Population: Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences.

Outcome measures

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Number of Clinically Relevant Minor Hemorrhages	2 Hemorrhages

PRIMARY outcome

Timeframe: Baseline to Week 24 (EOT) or ET

Population: Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.

Outcome measures

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Number of Trivial Hemorrhages	1 Hemorrhages

SECONDARY outcome

Timeframe: Baseline through Week 24 (EOT) or ET

Population: Intent to treat (ITT) population included all participants who were enrolled into the study.

Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.

Outcome measures

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Number of Participants With Intact Skin Healing	19 Participants

SECONDARY outcome

Timeframe: Baseline through Week 24 (EOT) or ET

Population: ITT population included all participants who were enrolled into the study.

Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.

Outcome measures

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Number of Participants With Improved Ulcer Healing	25 Participants

SECONDARY outcome

Timeframe: Baseline through Week 24 (EOT) or ET

Population: ITT population included all participants who were enrolled into the study.

A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.

Outcome measures

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Number of Participants Who Underwent Amputation All amputations (major and minor)	1 Participants
Number of Participants Who Underwent Amputation Major Amputation	1 Participants
Number of Participants Who Underwent Amputation Minor Amputation	0 Participants

SECONDARY outcome

Timeframe: Baseline through Week 24 (EOT) or ET

Population: The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.

Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through Week 24 (EOT) or ET

Population: The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through Week 24 (EOT) or ET

Population: The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.

MCVE were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 24 (EOT) or ET

Population: ITT population included all participants who were enrolled into the study.

The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.

Outcome measures

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
11-point Likert Pain Scale Baseline	2.4 Units on a scale Standard Deviation 2.1
11-point Likert Pain Scale EOT	2.2 Units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline and Week 24 (EOT) or ET

Population: ITT population included all participants who were enrolled into the study. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Outcome measures

Measure	Dalteparin n=62 Participants Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
36-Item Short-Form Health Survey (SF-36) Score Baseline: Physical Functioning (n= 43)	34.7 Units on a scale Standard Deviation 11.7
36-Item Short-Form Health Survey (SF-36) Score Baseline: Role-Physical (n= 43)	36.5 Units on a scale Standard Deviation 10.7
36-Item Short-Form Health Survey (SF-36) Score Baseline: Bodily Pain (n= 43)	45.1 Units on a scale Standard Deviation 9.6
36-Item Short-Form Health Survey (SF-36) Score Baseline: General Health (n= 43)	44.1 Units on a scale Standard Deviation 4.5
36-Item Short-Form Health Survey (SF-36) Score Baseline: Visibility (n= 43)	48.1 Units on a scale Standard Deviation 5.7
36-Item Short-Form Health Survey (SF-36) Score Baseline: Social Functioning (n= 43)	34.3 Units on a scale Standard Deviation 7.6
36-Item Short-Form Health Survey (SF-36) Score Baseline: Role-Emotional (n= 43)	36.6 Units on a scale Standard Deviation 13.8
36-Item Short-Form Health Survey (SF-36) Score Baseline: Mental Health (n= 43)	42.1 Units on a scale Standard Deviation 6.4
36-Item Short-Form Health Survey (SF-36) Score Baseline: Physical (PCS) (n= 43)	40.1 Units on a scale Standard Deviation 7.7
36-Item Short-Form Health Survey (SF-36) Score Baseline: Mental (MCS) (n= 43)	41.4 Units on a scale Standard Deviation 7.2
36-Item Short-Form Health Survey (SF-36) Score EOT: Physical Functioning (n= 57)	34.8 Units on a scale Standard Deviation 11.2
36-Item Short-Form Health Survey (SF-36) Score EOT: Role-Physical (n= 57)	35.1 Units on a scale Standard Deviation 11.0
36-Item Short-Form Health Survey (SF-36) Score EOT: Bodily Pain (n= 57)	45.5 Units on a scale Standard Deviation 11.3
36-Item Short-Form Health Survey (SF-36) Score EOT: General Health (n= 57)	42.9 Units on a scale Standard Deviation 4.6
36-Item Short-Form Health Survey (SF-36) Score EOT: Visibility (n= 57)	48.7 Units on a scale Standard Deviation 6.3
36-Item Short-Form Health Survey (SF-36) Score EOT: Social Functioning (n= 57)	35.1 Units on a scale Standard Deviation 4.5
36-Item Short-Form Health Survey (SF-36) Score EOT: Role-Emotional (n= 57)	36.3 Units on a scale Standard Deviation 14.9
36-Item Short-Form Health Survey (SF-36) Score EOT: Mental Health (n= 57)	42.2 Units on a scale Standard Deviation 7.1
36-Item Short-Form Health Survey (SF-36) Score EOT: Physical (PCS) (n= 57)	39.4 Units on a scale Standard Deviation 9.0
36-Item Short-Form Health Survey (SF-36) Score EOT: Mental (MCS) (n= 57)	41.9 Units on a scale Standard Deviation 7.9

Adverse Events

Dalteparin

Serious events: 11 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dalteparin n=62 participants at risk Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Blood and lymphatic system disorders Anaemia	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure acute	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial infarction	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	3.2% 2/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Erysipelas	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gangrene	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infected skin ulcer	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	3.2% 2/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Femoral neck fracture	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoglycaemia	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Carpal tunnel syndrome	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Dalteparin n=62 participants at risk Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Blood and lymphatic system disorders Anaemia	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial fibrillation	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure	3.2% 2/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hypothyroidism	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Panophthalmitis	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	3.2% 2/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoidal haemorrhage	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	3.2% 2/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Ulcer haemorrhage	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cystitis	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Diabetic foot infection	4.8% 3/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Erysipelas	3.2% 2/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Folliculitis	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infected skin ulcer	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	6.5% 4/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Orchitis	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Respiratory tract infection	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth infection	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Wound infection	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Chest injury	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	3.2% 2/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Wound	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Body temperature increased	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	3.2% 2/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteitis	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Sleep disorder	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary retention	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Decubitus ulcer	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Diabetic ulcer	3.2% 2/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dry gangrene	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin discolouration	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin ulcer	6.5% 4/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Urticaria	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Tooth extraction	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Circulatory collapse	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertensive crisis	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Intra-abdominal haematoma	1.6% 1/62 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER