2. Definition of outcomes and other treatments.

Study ID	Definition of	Definition of	Definition of	Definition of	Treatment for	Long‐term
First author, year	control of bleeding	five‐day failure of treatment	re‐bleeding	need of blood transfusion	failure to control initial bleeding	prevention of re‐bleeding
Westaby, 1989	Absence of active variceal bleeding either by repeat endoscopy or by nasogastric aspirate.	Not assessed.	Endoscopy proven variceal bleeding after stools had cleared of melaena.	Not reported.	Additional therapy if two or more tx were needed over two hrs. In both groups: vasopressine + NG, balloon tamponade or sclerotherapy. No predefined criteria.	EVS: sclerotherapy. Control: sclerotherapy 12 hrs after admission and then with the same schedule as EVS group.
Escorsell, 2000	24‐h bleeding free period within 48 hrs after randomisation. Bleeding was haematemesis, blood in gastric aspirate, hypovolaemia with melaena, blood in gastric aspirate, or bleeding at endoscopy.	Failure to control bleeding within 48 h or re‐bleeding within five days after control of bleeding.	New evidence of bleeding after a 24‐h bleeding free period.	To maintain haematocrit between 0.28 and 0.30.	Both groups: vasoactive therapy (except terlipressin), endoscopic therapy, balloon tamponade, surgical shunt, or TIPS.	Both groups, after the initial six to seven days of the study: endoscopic therapy, or pharmacological therapy, or combination or surgical shunt, or TIPS.
Di Febo, 1990	No haematemesis and/or melaena, Hb stable or drop less than 2g/dl, stable vital signs.	The used outcome was seven‐day failure, defined as failure to control bleeding within 48‐h or re‐bleeding between day two and seven.	Haematemesis and/or melaena or Hb drop more than 2g/dl or fall of vital signs in absence of haematemesis or melaena.	Not reported.	Both groups: sclerotherapy.	Not reported.
Shields, 1992	Cessation of bleeding assessed endoscopically 15 to 20 min after starting somatostatin or ten min after EVS.	Failure to control bleeding or re‐bleeding within five days.	Further haematemesis or melaena accompanied by either systemic disturbance or Hb fall.	Not reported.	Both groups: balloon tamponade.	Both groups: sclerotherapy
Planas, 1994	No haematemesis or melaena with stable systolic blood pressure and heart rate during the 48‐h trial period.	The used outcome was seven‐day failure, defined as failure to control bleeding or re‐bleeding within 48 h or re‐bleeding between day two and seven.	Recurrence of haemorrhage within five days after the 48‐h trial period: haematemesis or melaena associated with drop of systolic blood pressure more than 30 mmHg, HRmore than 120 or need of more than 2 blood units to maintain vital signs.	To maintain vital signs.	EVS: Somatostatin Control: EVS, Sengstaken Blackmore (SB) tube.	Both groups: Propranol plus isosorbide5‐mononitrate or long‐term sclerotherapy or shunt surgery in a randomised trial.
Escorsell, 1998	24‐h bleeding free period within 48 hrs from admission. Bleeding was haematemesis, hypovolaemia (systolic blood pressure less than 80 mmHg and heart rate more than 120), haematocrit drop more than 10 in six‐hour, blood in gastric aspirate.	Haematemesis or fresh blood in six consecutive hourly nasogastric aspirates and hypovolaemia, need of two blood units to maintain haemodynamic stability; need for further treatment or for alternative therapy.	Haematemesis, hypovolaemia (systolic blood pressure less than 80 mmHg and heart rate more than 120), haematocrit drop more than 10 in six‐hour, blood in gastric aspirate.	To maintain haemodynamic stability.	Treatment for re‐bleeding: alternative therapy, using either SB, terlipressin, TIPS, shunt surgery, or a combination of the above.	Both groups, after the five‐day study period: EVS, pharmacological therapy, or shunt surgery.
Sung, 1993	Absence of: recurrent haematemesis or melaena of more than 500 ml, systolic blood pressure less than 90 mmHg, heart rate more than 110, or 6 units of blood or plasma within 12‐h.	48‐h treatment failure was assessed and was defined as need to use balloon tamponade: this was used for recurrence of haematemesis or melaena of 500 ml or more, blood pressure less than 90 mmHg or heart rate more than 110 for two hrs, or more than 6 units of blood or plasma to sustain blood pressure.	Recurrent haematemesis or melaena of more than 500 ml, systolic blood pressure less than 90 mmHg, heart rate more than 110, or six units of blood or plasma within 12 hrs.	To sustain blood pressure.	Both groups: balloon tamponade (Minnesota tube).	Both groups: elective EVS.
Poo, 1996	Absence of recurrent bleeding within 48 hrs, defined as haematemesis or melaena or more than 3 blood Units to maintain systolic blood pressure more than 90 mmHg or heart rate less than 100.	Not assessed.	Recurrence of haematemesis or melaena or more than 3 blood Units to maintain systolic blood pressure more than 90 mmHg or heart rate less than 100.	To maintain systolic blood pressure more than 90 mmHg or heart rate less than 100	Both groups: balloon tamponade.	Not reported.
Jenkins, 1997	Haematemesis and/or melaena with instability of vital signs or fall of Hb requiring blood transfusion, over the 48 hrs following randomisation.	Not assessed.	Haematemesis and/or melaena with instability of vital signs or fall of Hb requiring blood transfusion.	Not reported.	Both groups: balloon tamponade.	Not reported.
Lopez, 1999	Based on endoscopy 24 hrs after starting therapy. Criteria were not reported.	Not assessed.	Not assessed.	Not reported.	Both groups: balloon tamponade.	Not reported.
Bildozola, 2000	Absence of fresh blood in the hourly gastric aspiration for 12 consecutive hrs together with stability of haematocrit and vital signs.	Persistence of bleeding more than 6 hrs; recurrence of bleeding (haematemesis or fresh blood in the gastric aspirate) requiring tree blood units in three hrs to maintain stable the haematocrit and vital signs (i.e., blood pressure more than 90 mmHg and heart rate less than 100).	Recurrence of haematemesis or melaena, haemodynamic instability ( blood pressure less than 90 mmHg and heart rate less than 100) and 5% haematocrit fall after initial control of bleeding.	To maintain constant haematocrit and vital signs.	Both groups: endoscopic therapy and/or balloon tamponade or surgery.	Treatment not reported, but all patients surviving the five‐day study period entered a randomised trial of treatment for long‐term prevention of recurrent bleeding.
Sivri, 2000	Stable blood pressure (no reduction more than 20 mmHg after reaching stable values); stable Hb (more than 9g/dl); haematocrit more than 30% and tx requirement less than 2/2h or less than 4/24h.	Not assessed.	Overt haemorrhage or aspiration of more than 100 ml of fresh blood; fresh melaena; fall of Hb more than 4g/72hr; heart rate more than 100 and blood pressure less than 100 mmHg in the presence of continuing melaena.	To maintain haematocrit more than 30%.	Alternative therapy or balloon tamponade.	Both groups: EVS.
Ramires, 2000	Absence of haematemesis or melaena accompanied by systolic blood pressure less than 100 mmHg or heart rate more than 100 within 48 hrs. Absence of bleeding at the 48‐h control endoscopy	7‐day failure: persistent bleeding, re‐bleeding or death	Haematemesis or melaena accompanied by systolic blood pressure less than 100 mmHg or heart rate more than 100. re‐bleeding was always endoscopically confirmed.	Not reported	Both groups: sclerotherapy	Not reported
Freitas, 2000	Absence of haematemesis or less than 100 cc of bright blood in naso‐gastric aspirate; no bright red blood per rectum; no haemoglobin decrease of more than 4g/dL in 48 hrs; absence of shock and melaena.	7‐day failure: persistent bleeding, re‐bleeding or death	Haematemesis or more than 100 cc of bright blood in naso‐gastric aspirate; bright red blood per rectum; haemoglobin decrease of more than 4g/dL in 48 hrs; shock and melaena.	Not reported	Both groups: emergency sclerotherapy. When this failed: balloon tamponade, surgery or other.	Both groups: EVS or band ligation at the end of the 48 hrs trial period
Yousuf, 2000	Absence of blood in gastric aspirate for at least 1 hour and stable vital signs after 12 hrs from randomisation	Not assessed	Fresh blood in gastric aspirate at any time following initial control of bleeding and unstable vital signs	Not reported	Not reported	Not reported
Silva, 2004	According to Baveno III	Not reported	New haematemesis, haemodynamic instability, need of transfusions to maintain Ht more than 27%	To maintain haemoglobin more than 8g/dl	Both groups: endoscopic therapy followed by TIPS incase of persistent bleeding	Not reported
Shaikh, 2002	Absence of re‐bleeding at 4 hrs	Not reported	New haematemesis or melaena with haemodynamic instability and/or need for transfusions	Not reported	Not reported	Not reported
	Abbreviations: tx = blood transfusion;Hb = haemoglobulin; h = hour; hrs = hours.