This site contains promotional information intended only for healthcare professionals resident in the United Kingdom
Sign in
Sign In or Register
Sign out

Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

See all Therapy areas

Explore Content

Information on how to access Fragmin® (dalteparin sodium) prescribing information and adverse event reporting can be found at the bottom of the page.

Efficacy and Safety Profile: 
VTE in Solid Tumours

Lee AY et al. N Engl J Med 2003;349:146–153 (CLOT)1.

Study Design:

A multicentre, randomised, open-label clinical trial in patients with active cancer and newly diagnosed, symptomatic proximal deep vein thrombosis (DVT), pulmonary embolism (PE) or both (N=676). Patients were assigned to receive either subcutaneous Fragmin® (200 IU/kg), once daily for five to seven days (maximum daily dose 18,000 IU) followed by oral anticoagulation with a VKA for six months (target INR, 2.5), or subcutaneous Fragmin® alone for 6 months (200 IU/kg once daily for one month [maximum daily dose 18,000 IU], followed by a daily dose of approximately 150 IU/kg for five months).

​​​​​​​Primary endpoint: First episode of symptomatic, recurrent DVT, PE or both, during a 6 month period.

​​​​​​​Secondary endpoint: Clinically overt bleeding and death.

​​​​​​​Of the 676 consenting patients, 90% of patients had solid tumours. The most frequent sites of solid tumours were:

  • Breast (15.9%)
  • Brain (3.9%)
  • Pancreas (4.2%)
  • Gynaecologic system (10.0%)
  • Genitourinary tract (12.7%)
  • Lung (13.3%)
  • Colorectal area (15.9%)


Symptomatic, recurrent DVT, PE, or both occurred in 8.0% (n=27) of patients in the Fragmin group and 15.7% (n=53) of patients in the VKA group over the six month study period (P=0.002). Treatment with Fragmin resulted in a 52.0% relative risk reduction of recurrent VTE versus VKA at 6 months (HR: 0.48; 95% CI: 0.30–0.77; P=0.002; absolute risk reduction = 8%). There was no significant difference between the number of patients in the Fragmin group and the VKA group who had major bleeding (6% vs. 4%; P=0.27), or any bleeding (14% vs. 19%; P=0.09).


In adult patients with active cancer and newly diagnosed, symptomatic proximal DVT, PE or both, Fragmin was more effective than a VKA in reducing the risk of recurrent VTE without increasing the risk of bleeding

Prandoni P et al. Blood 2002;100:3484–3488.2

Study Design:

Prospective, follow-up study in thrombosis patients (N=842) to determine whether those with cancer (n=181) have a higher risk for recurrent VTE or bleeding during anticoagulant treatment than those without cancer (n=661). Patients were treated with an initial course of high-dose adjusted i.v. standard heparin or body weight-adjusted LMWH. Sodium warfarin was started during the first week of treatment and continued for a period of at least 3 months.

​​​​​​​Primary endpoint: Cumulative incidence of VTE or bleeding over 12 months of anticoagulation treatment.


The 12 month cumulative incidence of recurrent VTE in cancer patients was 20.7% (95% CI, 15.6%–25.8%) versus 6.8% (95% CI, 3.9%–9.7%) in patients without cancer (HR: 3.2; 95% CI, 1.9–5.4). The 12-month cumulative incidence of major bleeding was 12.4% (95% CI, 6.5%–18.2%) in patients with cancer and 4.9% (95% CI, 2.5%–7.4%) in patients without cancer (HR: 2.2; 95% CI, 1.2–4.1).

​​​​​​​Recurrence and bleeding were both related to cancer severity and occurred predominantly during the first month of anticoagulant therapy but could not be explained by sub- or over-anticoagulation.


Patients with cancer were three times more likely to experience recurrent VTE, and twice as likely to experience major bleeding during anticoagulation treatment than patients without cancer. There appears to be an association between the extent of cancer at baseline and the subsequent risks of complications.

​​​​​​​Woodruff S et al. J Thromb Thrombolysis 2016;42:494–5043.

Study Design:

Post hoc analysis of the CLOT study, a multicentre, randomised, open-label clinical trial in patients with active cancer and newly diagnosed, symptomatic proximal DVT, PE or both (n=676). Patients randomly assigned to Fragmin received once-daily subcutaneous injections of Fragmin 200 IU/kg (maximum daily dose 18,000 IU) for 1 month, followed by injections of 150 IU/kg for the remaining 5 months. Those in the VKA group received once-daily VKA for 6 months, with initial overlapping subcutaneous Fragmin 200 IU/kg once daily for at least 5 days until INR was 2.0–3.0 for 2 consecutive days.

​​​​​​​Primary endpoint: Rates of recurrent VTE.

​​​​​​​Secondary endpoint: Incidence of bleeding events.


Overall, fewer Fragmin-treated patients (2/74 [2.7 %]) experienced  at least 1 days adjudicated symptomatic rVTE compared with VKA-treated patients (15/88 [17.0 %]; HR=0.15 [95 % confidence interval 0.03–0.65]; p=0.01).

​​​​​​​Bleeding event rates for both treatments were similar (p=0.47).


Compared with VKA, Fragmin significantly reduced the risk of rVTE in patients with cancer and renal impairment (p=0.01) while exhibiting a comparable safety profile.

VTE in Solid Tumours

Fragmin Tolerability

Find out more

Using Fragmin Needle-Trap

Click below to learn how to use a Fragmin Needle-Trap

Learn more

Categories of Anticoagulants

Find out more

Patient Resources

Discover our range of patient resources

Discover more

For UK Healthcare Professionals*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021



OK, We will need you to sign in before we can determine if you are aligned with a Pfizer promotional colleague.This is an interstitial message to prompt a HCP before they login.

If you have already registered with and select ‘yes’, you will be directed to the sign-in page where you will be required to enter your username and password.

Would you like to register or sign in now?