Table 2 Definitions and Description of Clinical Outcomes

Transplant Related Mortality

This is defined as the incidence of death from any cause at 100 days post Hematopoietic Stem Cell Transplantation.

Maximum grade of acute Graft versus Host Disease (GVHD)

The incidence of acute GVHD up to Day 100 will be compared. Acute GVHD will be graded according to the Przepiorka Criteria [14].

Serious Infection

Clinically important infections will be ascertained using Centre for Disease Control criteria [16]. Infections will include: serious infections such as nosocomial pneumonia; deep tissue infections (peritonitis, mediastinitis) and bacteremia from organisms not considered normal skin flora, and judged important enough to treat by the attending team. All grade 4 and 5 infections (according to the Common Terminology for Adverse Events v.4) will be recorded in the Data Collection Forms. In addition, the following information will also be recorded in the Data Collection Forms: Type of organism (bacterial, viral, fungal or protozoal) (suspected or documented).

Bearman Toxicity Score

This is a validated scoring system [17] to assess toxicity during HSCT. In this system, grade I toxicity is reversible without treatment and grade 2 is not life threatening, but requires treatment. Grade 3 requires life-support intervention and grade 4 is fatal. Regimen-related toxicity in each organ system was scored as the highest grade achieved in that organ system through day 28, except that deaths occurring after day 28 as a result of regimen-related toxicity occurring before day 28 are also scored as grade 4. Adverse events that could be attributed to infection (culture-documented), bleeding or other medications are not scored as regimen-related toxicity. The maximum toxicity is the highest grade recorded in any individual

organ system and the cumulative toxicity score is the sum of the highest grades recorded for all eightorgan systems.

Veno-Occlusive Disease

Diagnosis requires 2 of 3 criteria, occurring within 20 days of transplantation: 1) Bilirubin > 34.2 μmol/L (2 mg/dL), 2) Hepatomegaly or RUQ pain of liver origin and 3) > 2% weight gain due to fluid accumulation [15].

Bleeding

The WHO Scale [18] is a credible, standardized and validated scale to assess bleeding. Grade 3 and 4 bleeding will be recorded in the data collection forms.

Quality of Life

Both the FACT-BMT [20] and EQ-5D [19] scales will be used to document quality of life.

The FACT consists of 5 subscales that measure physical well-being, functional well-being, social/family well-being and emotional well-being. The BMT subscale of the FACT includes additional items specifically designed to test quality of life and symptoms specific to BMT patients. EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.