Appendix Table C24. KQ1 Outcome VI. Thromboembolic complications: Epoetin versus control; definition for thromboembolic events as defined in journal publications

Study / Predefined definition / TE recorded / Other information reported
Aapro 2008 / No / Yes / Serious TE versus non serious
Bamias 2003 / Yes for all adverse events: “Death or any event requiring specific treatment, admission to hospital or a life-threatening event was reported as serious adverse event”. / Yes
Blohmer 2011 / No, but TEE included deep vein thrombois and pulmonary embolism in results / Yes
Case 1993 / No / Yes
Chang 2005 / No / Yes / TE attribution to epoetin reported
Engert 2009 / No / Yes
Fujisaka 2011 / No / Yes
Henke 2003 / Vascular disorders were hypertension, hemorrhage, venous thrombosis and pulmonary embolism, and cerebrovascular disorders / Yes, including hypertension / Relation to study drug reported
Henry 1995 / No / Yes
Hoskin 2009 / No / Yes / Clinically relevant TE reported
Leyland-Jones 2005 / TVEs were compiled by medical monitors at Johnson & Johnson Pharmaceutical Research Division, based on WHO Adverse Reaction Terms 97 Q4. / Yes / Fatal TE reported. Relation to study drug reported.
Littlewood 2001 / Thrombotic or possible thrombotic event / Yes
Machtay 2007 / No / Yes / Relation to study drug reported
Milroy 2011 / No / Yes
Osterborg 2002 / No / Yes
Pronzato 2010 / Adverse events recorded regardless of their relationship to the drug and rated as mild, moderate or severe / yes
Ray-Coquard 2009 / Thrombovascular events were compiled by medical monitor, on the basis of WHO Adverse Reaction Terms 97 Q4. No systematic specific exam was carried out to evaluate the risk; only reported events and/ or abnormal results of tests ordered by investigators were taken into account. / Yes
Razzouk 2006 / Thrombotic vascular events (intravenous thrombus, chest pain, edema, thrombosis, disseminated intravascular coagulation, cerebral infarction and pulmonary thrombosis) were summarized by seriousness and clinical relevance. / Yes / Seriousness, resolution and relation to study drug reported
Savonije 2005 / Adverse events recorded regardless of their relationship to the drug and rated as mild, moderate or severe / Yes / Relation of TE to study drug reported
Thomas 2008 / No / Yes / Associated grade, time of incidence, treatment attribution, patient’s baseline traits and hemoglobin levels at time of TE incident reported.

TE: thromboembolic events, TVE: thrombovascular events


Appendix Table C24. KQ1 Outcome VI. Thromboembolic complications: Epoetin versus Control, Definition for thromboembolic events as defined in journal publications (continued)

Study / Predefined definition / TE recorded / Other information reported
Tsuboi 2009 / Safety was assessed by National Cancer Institute- Common Toxicity Criteria, vers. 2 / Yes / Relation to treatment reported
Wilkinson 2006 / No / Yes / Information about whether TE led to death and whether patients recovered from TE
Witzig 2005 / No / Yes / Grade of TE and relation to drug reported. Relation to Hb change recorded.

TE: thromboembolic events, TVE: thrombovascular events

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