Trial Outcomes & Findings for An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin® (NCT NCT01046903)
NCT ID: NCT01046903
Last Updated: 2012-02-27
Results Overview
Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.
Recruitment status
COMPLETED
Target enrollment
503 participants
Primary outcome timeframe
Baseline up to Week 5
Results posted on
2012-02-27
Participant Flow
Participant milestones
| Measure |
Dalteparin Sodium
Dalteparin Sodium (Fragmin) 2500 International Unit (IU)/0.2 milliliter (mL) and 5000 IU/2 mL subcutaneously (s.c) as per registered indications for 5 weeks.
|
|---|---|
|
Overall Study
STARTED
|
503
|
|
Overall Study
COMPLETED
|
475
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Dalteparin Sodium
Dalteparin Sodium (Fragmin) 2500 International Unit (IU)/0.2 milliliter (mL) and 5000 IU/2 mL subcutaneously (s.c) as per registered indications for 5 weeks.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Other
|
5
|
Baseline Characteristics
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®
Baseline characteristics by cohort
| Measure |
Dalteparin Sodium
n=503 Participants
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Sex: Female, Male
Male
|
163 Participants
n=5 Participants
|
|
Primary diagnosis
|
NA Participants
n=5 Participants
|
|
Age Continuous
|
63.5 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
340 Participants
n=5 Participants
|
|
Medical history
|
NA Participants
n=5 Participants
|
|
Procedures After Primary Diagnosis
|
NA Participants
n=5 Participants
|
|
Thromboembolic Disease Assessment
|
NA Participants
n=5 Participants
|
|
Prior Surgery History
|
NA Participants
n=5 Participants
|
|
Prior Study Medications
|
NA Participants
n=5 Participants
|
|
Concomitant Study Medications
|
NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 5Population: The Full Analysis Set (FAS) included all those participants who received at least 1 dose of the study medication.
Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.
Outcome measures
| Measure |
Dalteparin Sodium
n=503 Participants
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Physician's Assessment of Efficacy of Treatment
Good
|
2 Participants
|
|
Physician's Assessment of Efficacy of Treatment
Excellent
|
432 Participants
|
|
Physician's Assessment of Efficacy of Treatment
Very good
|
44 Participants
|
|
Physician's Assessment of Efficacy of Treatment
Fair
|
2 Participants
|
|
Physician's Assessment of Efficacy of Treatment
Poor
|
1 Participants
|
|
Physician's Assessment of Efficacy of Treatment
Not reported
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 5Population: The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.
Approved dosage regimens for Fragmin in major orthopedic surgery included; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.
Outcome measures
| Measure |
Dalteparin Sodium
n=503 Participants
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Participant's Dosage Regimen
Dosage Regimen 2
|
2 Participants
|
|
Participant's Dosage Regimen
Dosage Regimen 3
|
115 Participants
|
|
Participant's Dosage Regimen
Dosage Regimen 1
|
327 Participants
|
|
Participant's Dosage Regimen
Other
|
59 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.
Risk factors evaluated for vascular thromboembolism (VTE) were age (above 40 years, but age was not a strong risk factor as a prediction of potential VTE episode), gender (primarily females but males after 65 years also influenced VTE episode), obesity, pregnancy, liver disease, kidney disease, hormone therapy, immobilization, previous surgery, concomitant malignant disease, positive family history, varicose veins, smoking, chemotherapy, catheter in vein, Heart Failure III New York Heart Association (NYHA) and Heart Failure IV NYHA.
Outcome measures
| Measure |
Dalteparin Sodium
n=503 Participants
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Number of Participants With Risk Factors
Kidney disease
|
7 Participants
|
|
Number of Participants With Risk Factors
Varicose veins
|
181 Participants
|
|
Number of Participants With Risk Factors
Smoking
|
92 Participants
|
|
Number of Participants With Risk Factors
Chemotherapy
|
4 Participants
|
|
Number of Participants With Risk Factors
Catheter in vein
|
204 Participants
|
|
Number of Participants With Risk Factors
Heart failure III New York Heart Association(NYHA)
|
6 Participants
|
|
Number of Participants With Risk Factors
Age
|
353 Participants
|
|
Number of Participants With Risk Factors
Obesity
|
205 Participants
|
|
Number of Participants With Risk Factors
Gender
|
291 Participants
|
|
Number of Participants With Risk Factors
Pregnancy
|
12 Participants
|
|
Number of Participants With Risk Factors
Liver disease
|
8 Participants
|
|
Number of Participants With Risk Factors
Hormone therapy
|
20 Participants
|
|
Number of Participants With Risk Factors
Immobilization
|
51 Participants
|
|
Number of Participants With Risk Factors
Previous surgery
|
257 Participants
|
|
Number of Participants With Risk Factors
Concomitant malignant disease
|
11 Participants
|
|
Number of Participants With Risk Factors
Positive family history
|
16 Participants
|
|
Number of Participants With Risk Factors
Heart failure IV NYHA
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 5Population: The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.
Thromboembolism is the formation of blood clot in the blood vessels due to an embolus (a detached intravascular mass capable of clogging arterial capillary beds at a site far from its origin).
Outcome measures
| Measure |
Dalteparin Sodium
n=503 Participants
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Number of Participants With Thromboembolism
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 5Population: The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.
Major bleeding: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram/litre (g/L) (2 g/decilitre \[dL\]), clinically overt bleeding leading to transfusion of more 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 bleeding was defined as bleeding that did not meet the definition of major bleeding.
Outcome measures
| Measure |
Dalteparin Sodium
n=503 Participants
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Number of Participants With Bleeding
Major Bleeding
|
0 Participants
|
|
Number of Participants With Bleeding
Minor Bleeding
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 5Population: The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.
Participant's global evaluation of treatment for overall response and comfort was evaluated on the four point categorical scale: excellent, good, fair and poor.
Outcome measures
| Measure |
Dalteparin Sodium
n=503 Participants
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Participant's Global Evaluation of Treatment
Overall response (Excellent)
|
236 Participants
|
|
Participant's Global Evaluation of Treatment
Overall response (Good)
|
220 Participants
|
|
Participant's Global Evaluation of Treatment
Overall response (Fair)
|
20 Participants
|
|
Participant's Global Evaluation of Treatment
Overall response (Poor)
|
1 Participants
|
|
Participant's Global Evaluation of Treatment
Overall comfort (Excellent)
|
129 Participants
|
|
Participant's Global Evaluation of Treatment
Overall comfort (Good)
|
238 Participants
|
|
Participant's Global Evaluation of Treatment
Overall comfort (Fair)
|
106 Participants
|
|
Participant's Global Evaluation of Treatment
Overall comfort (Poor)
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 5Population: The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.
Tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.
Outcome measures
| Measure |
Dalteparin Sodium
n=503 Participants
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Physician's Assessment of Tolerability of Treatment
Excellent
|
354 Participants
|
|
Physician's Assessment of Tolerability of Treatment
Very good
|
116 Participants
|
|
Physician's Assessment of Tolerability of Treatment
Good
|
10 Participants
|
|
Physician's Assessment of Tolerability of Treatment
Fair
|
0 Participants
|
|
Physician's Assessment of Tolerability of Treatment
Poor
|
0 Participants
|
|
Physician's Assessment of Tolerability of Treatment
Not reported
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 5Population: The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.
Administration schedule for Fragmin in major orthopedic surgery Included was categorized as; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.
Outcome measures
| Measure |
Dalteparin Sodium
n=503 Participants
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Administration Schedule of Treatment
Other
|
59 Participants
|
|
Administration Schedule of Treatment
Administration Schedule 1
|
327 Participants
|
|
Administration Schedule of Treatment
Administration Schedule 2
|
2 Participants
|
|
Administration Schedule of Treatment
Administration Schedule 3
|
115 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 5Population: Data was collected but not statistically summarized for analysis.
Compliance was defined as participants documented with Dalteparin Sodium up to 5 weeks after initiation of thromboprophylaxis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 5Population: The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.
Hematoma is a localized collection of blood outside of a blood vessel. It includes subcutaneous hematoma and injection-site hematoma.
Outcome measures
| Measure |
Dalteparin Sodium
n=503 Participants
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Number of Participants With Hematoma
|
2 Participants
|
Adverse Events
Dalteparin Sodium
Serious events: 26 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalteparin Sodium
n=503 participants at risk
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.20%
1/503
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
Gastritis
|
0.20%
1/503
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
Subileus
|
0.40%
2/503
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
Device dislocation
|
0.20%
1/503
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
|
0.20%
1/503
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
Pyrexia
|
0.20%
1/503
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
Postoperative wound infection
|
0.20%
1/503
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
|
0.20%
1/503
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
|
0.60%
3/503
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
Periprosthetic fracture
|
0.40%
2/503
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
Hypokalaemia
|
0.80%
4/503
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
Paralysis
|
0.20%
1/503
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
Sciatic nerve palsy
|
0.20%
1/503
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
Oliguria
|
0.20%
1/503
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
Pulmonary embolism
|
0.40%
2/503
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 sensitisation
|
0.20%
1/503
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
Deep vein thrombosis
|
0.40%
2/503
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
Haemorrhage
|
0.20%
1/503
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
Lymphoedema
|
0.60%
3/503
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
Thrombosis
|
0.20%
1/503
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 Sodium
n=503 participants at risk
Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
0.40%
2/503
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
|
0.20%
1/503
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.99%
5/503
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
Arrhythmia
|
0.20%
1/503
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
Dyspepsia
|
0.20%
1/503
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
Gastrointestinal disorder
|
0.20%
1/503
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
Gastrointestinal motility disorder
|
0.20%
1/503
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
|
0.80%
4/503
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
Vomiting
|
1.4%
7/503
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
Device dislocation
|
0.20%
1/503
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
Injection site haematoma
|
0.20%
1/503
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
|
0.40%
2/503
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
Pyrexia
|
0.20%
1/503
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
Soft tissue inflammation
|
0.20%
1/503
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
Asymptomatic bacteriuria
|
0.20%
1/503
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
Postoperative wound infection
|
0.20%
1/503
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
|
0.20%
1/503
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
|
0.20%
1/503
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
Anaemia postoperative
|
0.20%
1/503
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
Anaesthetic complication
|
0.20%
1/503
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
Periprosthetic fracture
|
0.20%
1/503
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
Post procedural oedema
|
0.20%
1/503
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
Procedural vomiting
|
0.20%
1/503
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
Subcutaneous haematoma
|
0.20%
1/503
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
Gout
|
0.20%
1/503
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
Dizziness
|
0.20%
1/503
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
Hypotonia
|
0.20%
1/503
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
Anxiety disorder
|
0.20%
1/503
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
Insomnia
|
0.99%
5/503
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
|
0.20%
1/503
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
Pruritus
|
0.20%
1/503
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
|
0.20%
1/503
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
Haematoma
|
0.40%
2/503
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
Haemorrhage
|
0.99%
5/503
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
Hypertension
|
0.20%
1/503
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
Hypotension
|
0.20%
1/503
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
Lymphoedema
|
0.40%
2/503
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
Venous thrombosis limb
|
0.20%
1/503
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
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