Pt 004387 at site GBR0114 was put on Apixaban 2.5mg twice daily starting on 16Feb2018 but this was for atrial fibrillation rather than VTE. Should the site report this treatment on ClinPal?

We have to absolutely report this treatment. The rationale is that we have to document all relevant medication regardless of the reason it was given … we are not just collecting VTE treatment in the CRF. We would be a missing a crucial part of this patients medical management if we omitted capturing this treatment with a NOAC.

Could you please confirm question raised by site CZE0015 on definition of Distal and Proximal DVT? Distal DVT – from v. poplitea and v. tibialis Proximal DVT – v. femoralis

Below is not quite right – popliteal is considered proximal:

Proximal is popliteal, femoral, iliac;
Isolated distal has no proximal component and is below the popliteal – typically there are 3 calf veins – anterior tibial, posterior tibial and peroneal.
Separately, another area of confusion that sometimes comes up – the femoral is sometimes called the superficial femoral vein. The unwary think (not unreasonably!) that it is a superficial vein – however, that is not the case, it is a deep vein and therefore the patient has a DVT rather than superficial vein thrombosis.

A site is asking whether they need/may check PE method “Lung Scan (Ventilation Perfusion Scan)” in case they have actually confirmed the diagnosis with “Lung Scan (Ventilation Scan)”. As per the PI Ventilation Perfusion Scan method is more precise method and not the same with Ventilation Scan. Could you please check with TRI/Clinpal whether they consider both methods as equal?

Ventilation scan without perfusion scan is inadequate to diagnose PE. The tick box in the CRF reads "Lung Scan (Ventilation Perfusion Scan)" and this means that both is required to show the ventilation/perfusion mismatch which is the objective criterion to confirm PE.

Is duplex scanning allowed for the diagnosis of DVT?

Duplex scanning is covered by ultrasound

Can we clarify the term Acute medical illness?

For example, Heart failure NYHA class III or IV, Active cancer (e.g. admitted for chemotherapy or for treatment of a complication of the active cancer), Acute ischemic stroke, Acute infectious and inflammatory diseases, including acute rheumatic diseases, Acute respiratory insufficiency.

 The patient was assessed for eligibility within 30 days, but is only returning at month 3 to give consent, will I be doing baseline and the 3 month the day they consent, in other words I would enter all info into the baseline from "diagnosis to 1 month" and then enter all info " >1 month to 3 months" into 3 month follow up.  Also, what about the questionnaires...will I only have the patient do one set done when they sign consent (we are at 90-100 days since diagnosis, there should be 2 )

If the patient returns at month 3 to give consent, the data for the patient  between diagnosis and 30 days post diagnosis should be entered for baseline, the data between 1 month and 3 months should be entered for month 3.  Patients should only complete the questionnaires once they have given consent. Therefore, if the patient only gives informed consent at month 3, the patient should only complete month 3 questionnaire.  The baseline questionnaire will be considered as missing for data analysis.

If the patient comes in on day 93 or day 95, would this data be entered under Month 3 or Month 6.

Any data collected after the milestone date should be entered for the next milestone

"During the SIV, a question was raised related to Protocol – 6.2.15: ‘6.2.15 Hospitalization/Interventions All hospitalizations will be captured on the eCRF, the data will include duration of hospital stay, reason for hospitalization, any VTE-related thrombosis or bleeding, whether the hospitalization was expected or unexpected and the intervention for VTE required if any.’ 1.  Should all hospitalization of subject be captured in EDC or only hospitalizations related to VTE? "

"We are capturing all hospitalisations. The current list of options are:
Recurring VTE Episode                                                                                                                                                                                                                                                                                  Bleeding
Diagnostic procedure/ routine check up                                                                                                                                                                                                                Complication of VTE                                                                                                              Cancer
Surgery/Other Intervention                                                                                                                                                                                                                                                                 Other

"The units in which lab results are reported differ depending on laboratory, most often they are g/L for Haemoglobin and µmol/L for Creatinine. Could you please advise if there is approved standardized tool, which site could use to convert values to report them in unites pre-defined in Clinpal? Can site convert the values using their own tools, e.g. internet based calculators? We found the below converter, do you think it is acceptable to advise sites to use it? http://dwjay.tripod.com/conversion.html "

If the sites are reporting the lab results in a different units, then these will have to be converted by the site before entering the data into the system.                                                                                                         It will be good if all sites use the same conversion. 

For major bleeding, “a fall in haemoglobin of 2 g/dl or more” should compare to previous lab or baseline?

fall in haemoglobin of 2 g/dl or more between two consecutive measurements regardless the time in between

If the data only need to be collected each milestone (only collect date of month 3) or it is ALL data that required from the previous to the requested time point (collect data from baseline all the way to month 3)?

It is all data collected between the last milestone and the current milestone which needs to be entered.  So at month three,  the site will need to record data collected any time between baseline and month 3.

The race and tobacco use are not common data in Taiwan medical chart, should we ask PI to document these data in the medical chart?

Yes if these data are collected in CRF, we will need these to be recorded in the Medical Chart as source data. 

When a patient is consented and enrolled, how far back should their hospitalizations’ information be dated in Clinpal?

If the question is if we need to collect information about the patient’s hospitalisation data (ie date when they went into hospital, whether it was planned or not), then we do not need this information prior to the date of diagnosis.
If the question is about hospitalisation as a risk factor for VTE, then we will need to collect this data during the past 3 months of diagnosis.

What option should be selected as care setting - medical insurance or public health - for subjects with mixed care.

As per the CRF, for mixed medical treatment fund, the options are
o all cost covered by medical insurance
o partial costs covered by medical insurance
o all cost covered by medical insurance
If the patient’s treatment is funded by both sector, then the site should select “partial costs covered by medical insurance”.

If an oncology patient is very ill and cannot complete the questionnaires or receive follow up calls – is any further action due on the site’s end?

The site should follow up with the patient's GP to obtain any clinical data.  Patients questionnaires can be omitted if patients are unable to complete them

A study nurse asked me if she needs to call all the patients for their follow ups every 3 months as they don’t have access to the medical records of other physicians (for example when they pass by the Thrombotic service or a general practitioner). What should I answer her, cause in normal circumstances they wouldn’t call the patients?

The follow up visits in protocol are not any additional measures, these are as per a routine VTE practice. If a patient is signing off ICF and agreeing to participate then as per below they agree to come for FU visits and in some cases they can be contacted by the physician.
As per ICF – “As part of the study your doctor will provide information on your health. They will collect this by reviewing your medical history from your medical records. Some information about your progress will be provided from your medical records at certain time points. This will be firstly at diagnosis and up to 30 days after your diagnosis and then at 1, 3, 6, 12, 24, and 36 month intervals following your diagnosis. We will follow your progress for a minimum of 3 years. In case you haven’t visited your doctor between two of these time points, your doctor or a delegate from clinic might contact you to check on your progress. The aim of this will be to ensure that everything that has happened to you in this period has been recorded. Following the 3 year period we would like to check on your overall health once a year for up to 2 years. We will only do this if we have your consent”
1. As the IRB of each site has approved the ICF the site is bound to follow the ICF procedure, which requests their follow up by phone in exceptional cases
2. On the other hand we will also be instructing sites to check medical records but in some countries the sites do not have access to medical records of patients directly and in those cases the only way for site is to phone patients.
3. Also the sites might need to FU with patients on phone for questionnaires or any other events
The bottom line is if a patient cannot come for fu visit then for any missing data the site is bound to contact them to obtain required information per protocol.

Can they enroll patients which are being treated by the PI temporarily and then go back to their GP/treating physician and there is no long-term follow up envisioned with the PI’s site?

These patients can be enrolled as long as the patient records are accessible upon request from the PI to the treating physician/medical care.
Per section 4.3 of the protocol –
In case no patient data or patient visits have been recorded in the patient’s medical records at the site (i.e. a patient has not been seen by his treating physician) during the months following the last data entry, a follow-up phone contact will be made by the site and documented to verify that all events are being captured and patients are not lost to follow up.

The PI questioned if there is specific reason why STEMI is observed in a DVT study. He mentioned that DVT is vein related while STEMI is artery related disease.

We are also interested to capture other thromboembolis events such as arterial and cardiac thrombosis although these are different pathophysiologies. We also capture other types of thromboembolic events in GARFIELD AF since both studies are anticoagulation registries

Are post-op VTE events, e.g. post hip surgery or post varicose vein surgery included in this registry?

So just so we can answer correctly the question is: are VTE events that are diagnosed and treated following surgery e.g. post hip surgery or post varicose vein surgery included in the registry? If that is the question then yes they are included.

Is there any reason for the physicians only assess the 7 clinical physical signs of the Villalta scale at month 36 , and NO need to assess at baseline, 3, 6, 12 months? This is a question from site why physicians only assess at month 36.

GARFIELD-VTE is a non-interventional registry and therefore, we cannot require that personal patient visits take place at predefined time intervals unless the examination is required by the disease or doctor’s routine treatment. Therefore, we translated the seven clinical signs originally to be assessed by the physician into patient language and included these questions in the patient questionnaire. However, doctors who see the patients at 3, 6, 12 months anyhow are more than welcome to also answer these question based on patient visits. Thus, the minimum requirement of follow up visits is limited in the protocol to the end of the study period or the last patient visit if the patient drops off before month 36.

Why is VTE at jugular vein an exclusion? Explanation.

I’d not recommend to enrol the patient because this is special or unusual site thrombosis and would need be kept separate from statistics. The jugular vein is not part of the deep venous system and in particular, if jugular vein thrombosis is due to lymphoma, i.e. compression from external site, the effectiveness of anticoagulation or thrombolytic treatment cannot be fully assessed as the external compression of the vein will remain.

Can a patient enter the study if he had superficial vein thrombosis but has reached the perforated vein

If superficial vein thrombosis that has reached the perforated veins in the calf, the patient should not be included. However, thrombi that have grown via the sapheno-popliteal- or sapheno-femoral junction into the deep venous system should be included.

Does DVT in this protocol include only iliac-femoral

No. It is attributed to the location of the thrombosis above confluence. Patients with thrombus in a vein related anatomically to the deep, but located below the popliteal vein can be included if treated

Should patients be symptomatic in order to be screened?

Patients to be included must have an event of acute VTE which requires treatment. If this event has been detected from screening for cancer (e.g. incidental PE detected by CT examination) and the investigator decides to treat this PE, the patient should be included.

If a patient was within 30 days of diagnosis but not start any treatment, could we enroll this patient

No. Patients who have not started any treatment are not be enrolled in GARFIELD-VTE

Is a patient also eligible when the VTE is coming from the superior mesenteric artery?

Mesenteric artery thrombosis is not VTE and therefore, it does not qualify for enrollment in GARFIELD-VTE.

Patient was on long term anti-coagulants for previous DVT, he stopped 2 days before the invasive procedure (as per standard surgery protocol) and he developed a new DVT. Can the patient be enrolled?

Obviously, for this patient treatment of the previous event had not been completed but only interrupted due to surgery. Thus, the patient should not be enrolled.

Patient came with an acute coronary syndrome and had a Coronary catheterization through the Common Femoral Artery on 2SEP2015. On 14SEP2015 the patient came and was diagnosed with DVT.  PI wants to know if patient can be enrolled because he believes that the Coronary Cathetization had accelerated the DVT because the External iliac vein is next to the Common Femoral Artery. He said that this was NOT a catheter- induced DVT because the catheter had entered in an artery and not in a vein, which makes the difference. He believes that the DVT was caused because of the immobilization that he prescribed and the pressure bandage he made of the patients. According to him, she had kept them for about 36 hours whereas he told her to do it for no longer than 8-12hrs.

I do not see a contraindication for this patient to be included in GARFIELD-VTE although this patient is a challenging special case. The treatment options for this patient are limited because this patient requires dual antiplatelet therapy for secondary prevention of ACS and therefore, the bleeding risk is markedly increased for any chosen type of anticoagulation therapy. It may happen that the investigator will not use regular conventional standard anticoagulation or NOAC therapy according to labelling but will individualise therapy according to the special circumstances of the patient. We may face difficulties to statistically group this patient at the end. Thus, I think the patient can be included although he/she would not be an ideal candidate.

The site of the thrombus is Superior Sagittal  right transverse venous sinus at the brain which we think now is not eligible. Can you consider if the patient can be included

This belongs to the group of unusual site thrombosis and venous thrombosis in unusual sites are rare and heterogenous manifestations of venous thromboembolism (VTE). These uncommon diseases are each characterized by peculiar pathophysiological and clinical features, mainly reflecting the different characteristics of the organs of origin. Moreover, the relative frequency and importance of risk factors associated with their development may be different compared to those of the classical manifestations of VTE, such as deep vein thrombosis of the lower limbs or pulmonary embolism. Therefore, the patient should not be included

Patient had DVT on 9AUG2015. 0n 15AUG2015 by means of scintigram PE was discovered. Is the PE considered distinct from the DVT or is it within the same category of event? How should this be entered in the EDC?

It is correct that DVT and PE are the same entity of disease and in cases where PE is diagnosed shortly after the diagnosis of DVT, it may be difficult to distinguish between "DVT plus PE" as qualifying diagnosis for enrollment or "DVT" as qualifying diagnosis and PE as recurrent VTE event. We discussed the definition of recurrent VTE during the steering committee meeting in London since we were aware about the uncertainties related to the discrimination of  "same event" and "recurrent event" in the early treatment phase. This relates in particular to patients with DVT diagnosed first and PE diagnosed shortly thereafter. The main question is if the patient had new clinical symptoms which triggered the diagnosis PE. In case the diagnostic examination of PE was  done without clinical symptoms of PE, this would qualify the patient to enter the study with "DVT plus PE". Recurrent VTE has been defined as "onset of new symptoms diagnostically confirmed". In brief, "new clinical symptoms = recurrent event". "No new clinical symptoms = same event".

The echo report of one patient showed: 1.Partial thrombosis of the right posterior tibial vein. 2.Left side deep veins are within normal limits. Since this patient is not typical VTE , could this patient be enrolled?

If this was a symptomatic thrombosis and the patient gets treatment for this event, then patient should be included. Of course, the patient also needs to agree for the long-term follow up

 Could we enrol a patients who has dementia and will not be able to complete questionnaires?- If we chose to enroll the patient, would we consider this a protocol deviation?

It is at the discretion of the investigator to decide whether the patient should be included or not into the study based on the inclusion and exclusion criteria.  If the investigator decides that the patient is eligible, then a 'responsible person' representing the patient should also sign the informed consent.  It is also at the discretion of the investigator to decide whether the patient is able to answer the questionnaires. 

I've been looking at patients are not enrolled because they were > 60 days since diagnosis. They now come to the clinic for regular visits, there are some patient that are now at 90 days even 100 days since diagnosis but were screened within the 30 days of diagnosis. What I understood is that they can still be considered for the study, is that correct?

As per protocol, the assessment of eligibility has to be completed within 30 days of diagnosis.    If assessment of eligibility was done at 30 days after diagnosis, but patient is only returning 3 months after diagnosis to give informed consent, the patient can still be enrolled. However, no data can be entered into the eCRF until consent is given.  Since this is an observational study, we are not interfering with the patient’s routine practice. 

Can we include patients with cases of provoked VTE?

Depending on the provoking factors.  Refer to protocol section 6.2.5

The PI asked whether SVT (superficial vein thrombosis) includes femoral arterial thrombosis – could you please advise?

Superficial vein thrombosis and femoral arterial thrombosis are completely different anatomic entities and both cannot be included in GARFIELD VTE

Are post-op VTE events, e.g. post hip surgery or post varicose vein surgery included in this registry?

Post-op VTE events are eligible for inclusion in GARFIELD VTE as long as the diagnosis of VTE has been objectively confirmed

Does the patient have to give informed consent within 30 days or can they consent later. If they consent later, do we have a recommendation of when they should come back

It is not necessary to obtain patient’s consent within 30 days.  However, no data can be entered into the eCRF until consent is given.  Since this is an observational study, we are not interfering with the patient’s routine practice.  Therefore, the recommendation is to get the consent of the patients at the next vis

 This patient has been hospitalized since last week for pulmonary thrombosis and his doctor is not sure how long he will live.  Can this patient be included?

If life expectancy is short due to concomitant diseases, e.g. cancer we should not include the patient.  In the protocol we only have as exclusion criterion "Patients for whom long-term follow up is not envisaged within the enrolling hospital or the associated primary care physician".

Regarding inclusion criteria, how to clearly define the recurrent VTE patients have completed treatment for the previous VTE episode?

Any patient who has finished therapy for a previous VTE event and requires therapy for another event (including events at the same site of the previous one) can be included                            in GARFIELD VTE regardless the duration of the treatment pause between the two episodes.

Can we include HIV patients with life expectancy of <3 years?

HIV is not a reason for exclusion. With modern types of medications their average life expectancy can be quite long

Is patient who has Budd-Chiari Syndrome is eligible for this study?

Patients with Budd-Chiari syndrome should not be enrolled in the study

Site informed that they have potential patient who has thrombosis in the vein in abdominal which contains blood flow to lower extremities. So site is not sure whether it is eligible or not because it is not thrombosis exactly at lower extremities.

A patient with advanced malignant disease which may also mechanically affect the deep venous system. I would recommend not to include the patient since the patient needs very individualised treatment

Patient had underwent superficial thrombophlebitis (i.e. not deep vein thrombosis), for which they were anticoagulated for about 4 months. Had LMWH + warfarin. Should be this mentioned in EDC? If yes in which part? There is no concomitant medication with Clexane or Warfarin.

The site should report the AC treatment to the eCRFs regardless of the reason it was given as we have to document all AC treatment and not only the treatment given for VTE in order to fully document patient’s medical management.

However this is only true if the patient underwent superficial thrombophlebitis during the follow up period. If this was a Baseline event and the patient didn’t have DVT then they may not be eligible for the study. Please clarify with the site.

Unscheduled Villalta questionnaire - I just want to clarify which patients we should conduct this assessment on. Is it only for patients who are due for the month 36 milestone? Or do we do it for all enrolled patients?

This assessment is an unscheduled assessment and could be conducted at any time point.

So apart from the patients who are due for the 36 month milestone, any patients at any time point of their participation could be contacted and asked about their PTS symptoms.

This includes:
1) patients that had their 36M visit in the past without having the Physician’s Evaluation of PTS using the Villalta scale. You can contact these patients and complete the unscheduled patient’s assessment instead in order to fully complete the follow-up of the patient,
2) patients that didn’t manage to complete the scheduled 24M Villalta questionnaire and they are willing to go through the assessment over the phone.

This “unscheduled” Villalta doesn’t replace the scheduled Villalta assessments but it is an supplementary option when it is not feasible to conduct the scheduled assessments.

An issue with the PRO questionnaires is causing some to be shown as 'missing' despite the information being complete in the database.

This was caused by an EDC upgrade and can be corrected by marking questionnaires as 'Not done'.

The option ‘not done’ is only available for the whole questionnaire, not for each limb, separately. Consequently, Villalta scale appears as missing for many patients. The reason is that, originally, there was a questionnaire for left limb and another for right limb so patients only completed the one for the limb with thrombosis symptoms.

To avoid data loss you are advised to mark as ‘not known’ what is not completed. However, it is known that the questionnaire for the other limb was not completed because there was no thrombosis. In any case, ‘not known’ is still more accurate than ‘0’, describing the situation much better.

For patients that had their 36M visit in the past without having the Physician’s Evaluation of PTS using the Villalta scale. Please clarify if these sites could contact these patients and complete the unscheduled patient’s assessment instead in order to fully complete the follow-up of the patient?

Throughout the study the patients were allowed to complete the questionnaires at any time point. The Milestones were only indicative. We provided a rough timeframe of around 1 month before and after each Milestone to complete each questionnaire, however we also invited the patients to fill in the questionnaires at any time point as long as they provided the date of completion.

The study protocol allows this flexibility. In paragraph 4.3, page 22 it says “the study protocol does not dictate follow-up frequency or timing”, “…data will be collected approximately at Baseline, 3, 6, 12, 24 and 36 months after diagnosis through review of patient notes and medical records. These time points will be used as markers for collection of all data from the preceding period.”

We are just repeating the same instructions for 36M Milestone as for previous Milestones.

Until the closure of each site, they will have the opportunity to collect and enter patients’ data on the database.

Please note that one of sites’ responsibilities for the 36-month follow up is the PTS evaluation using the Villalta scale so in order to fully complete the assigned responsibilities we are kindly asking them to complete the unscheduled patient’s assessment if they were not able to conduct the physical assessment using the Physician’s questionnaire. If this is not yet feasible, they can always mark the relevant form as Not Done.

Will old PI's names be included in publications if a PI change occurs?

We will most likely keep both names in the publication as they have still contributed to the study.

On M36, site selected that patient had cancer event since last milestone, however, it was 3 days after the due 36M. As M36 will be the last milestone, how should site answer to the Cancer question at M36?

The site should leave the Cancer event in the event folder and select the NO option in the relevant question of the Milestone form (Has there been a cancer event since the last milestone).

In a letter sent from TRI it said that: "Until this form is available please record the responses on a copy of the questionnaire (patient's Villalta questionnaire). " I checked the 36M Villalta entry page in Clinpal and I found that there is not distinction of left leg or right leg. Could you confirm that even though the unscheduled patient's assessment is done using patient's Villalta questionnaire which has distinction of left leg and right leg, the site can enter the patient's data, whichever the leg has symptoms, to the 36M Villalta?

Not really. The site will enter patients’ responses to the new form of patients’ Villalta that will be added on ClinPal at the end of July and it will be titled “Unscheduled patients’ assessment of PTS symptoms according to the Villalta scale”. This form will be exactly the same as the form you know and will have two parts for left and right leg respectively.
Regarding the 36M Villalta, they need to mark as not done.

Will all PIs (Past and present) be listed in publications? Also, will sub-Is be listed?

Yes, old PIs will also be included in publications as they have contributed to the study. Sub-Is will generally not be listed unless they have a signed contract.

A site has found out that a patient had a PE after their 36M follow up whilst collecting data for the unscheduled villalta. Can this information be captured in the EDC or is it not valid as the event took place after follow up was completed?

The site doesn't have to enter this PE event since it occurred after the 36M follow up period. Generally speaking the Stats team will truncate follow up in their programs at 3 years so you don't need to worry if a site enters an event after the 3 years follow-up period.

According to the letter from 30May19, PTS Questionnaire can be applied by phone. Can anyone, that is delegated, from the site apply this questionnaire or only the designated nurse is allowed (as per Jun2018 letter)? If the site staff that is not a nurse applies it, how can we proceed?

The Physician’s PTS (Villalta) should be completed by the person appointed for the patient’s routine care and should be done in person. However, an unscheduled Patients Villalta can be done via phone call (instead of performing Physicians’ Villalta or in addition to performing the Physicians’ PTS (Villalta)). The patient Villalta can be performed by anyone delegated this task as it is a patient reported outcome and the person taking the information is only transcribing what the patient is reporting.

The 36M PTS Questionnaire through phone can also be collected on the 36M folder as the physical evaluation or it should be included into the “Unscheduled”?

No, if the 36M physicians PTS (Villalta) cannot be done in person, then instead, the site should try to do a telephonic assesment using Patients Villalta (not the Physicians Villalta). This 36M Patients Villalta (done over the phone) should be entered in Clinpal in the “Patient Reported Outcomes” folder as an “unscheduled patients assessment of PTS symptoms according to Villata Scale”.

If the sites have Creatinine data which was performed within the period described in the list of missing Creatinine, should the sites change the entry on Clinpal?

The site needs to add the missing value and not to replace the value already entered. By clicking the plus button on the right side, a new row appears where they can enter the missing value.

Site just asked after 2 years storage period can they destroy the ISF as according to their local law and CTA, storage will be just up 2 years, or TRI would like to receive it?

Firstly please do not advise the sites to send their ISF to the Sponsor after the expiration of the archiving period. This applies to all VTE sites. No ISFs should be sent back to the sponsor.

Secondly, the sites need to follow GCP and local regulatory requirements.

The VTE protocol states in section 10.4 that “The PI will retain all essential documents associated with the Registry according to local regulations” and the CTA doesn’t state any specific requirements for archiving.

Therefore the sites need to follow GCP and local regulatory requirements. About documents destruction, this is something the sites need to decide after the expiration of the 2-year archiving period.

Can I ask a question regarding the care setting question. I just realised that the question we are asking at the end of the study (within the library) is exactly the same as the one asked at baseline and then at each milestone, and the answers (so far that I’ve seen) are identical for each one. Can you let me know the point of gathering this information again? It’s not a big deal if we have to collect it as it can easily be done at close out, I was more just wondering.

The difference is that the care setting questions in the Milestones ask for the facility that the patient was followed up at that Milestone and not the site that participates in VTE and it is common that these two are not the same as we are not asking the sites to invite the patients to their facility during follow-up.

Some requested eDC [site data] to be burnt on CD and provided to the sites prior CoV. I believe these data can be provided electronically but please share details and timelines when we can expect this data.

We are not able to provide patient data files to sites before the database is locked, the data is extracted from our vendor’s database and converted into a usable/readable format. The database lock will take place when all study sites are closed out.

Please could you provide further clarification on how to copy responses from the Physcian's to Patient's Villalta? In cases where the over the phone option was incorrectly selected at the 36M Physician's Villalta.

We’d like to provide further instructions on how to copy patients’ responses from the Physician’s to Patient’s Villalta when the assessment of the clinical signs was made by the patients (with no interpretation by the site, scenario No1 below).

In particular, the score ratings of the two Villalta versions are not the same. Physician’s Villalta is using the None/Mild/Moderate/Severe rating while the Patient’s Villalta is using a scale from 0 to 10 to assess the severity of the PTS signs and symptoms.

If the sites find it difficult to convert the one rating into the other, please let them know that the equivalence between the two scores is the following:

Physician's Villalta score None (0)
Patient’s Villalta score 0

Mild (1)
1 2 3

Moderate (2)
4 5 6 7

Severe (3)
8 9 10

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    Total patients 10,869
    Recruitment Recruitment closed
    Follow-up Follow-up ongoing
    Study end: 2020

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        To find out more about GARFIELD-VTE, please contact the Thrombosis Research Institute

        E: garfield@tri-london.ac.uk
        T: 0203 198 9947