An Efficacy and Safety Study of Decitabine in Participants With Myelodysplastic Syndrome (MDS)

Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as\<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin \>=11 gram (g) per deciliter (dl), platelets \>=100\*10\^9 liter (l), neutrophils \>=1.0\*10\^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by \>=50% over pre-treatment but still \>=5%.

Time frame: Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)

Population: The efficacy-evaluable (EE) population included all participants who received at least 2 cycles of treatment. Participants who died before receiving 2 complete cycles or were taken off study due to progressive disease were included. Here 'N' specifies those participants who were evaluable for this outcome measure.

Duration of hospitalization was calculated for each participant, using the sum of all hospital days by subtracting the date of discharge from the date of admission.

Time frame: Cycle 1 up to Cycle 8, each cycle of 28 days.

Population: ITT population was defined as all participants who had received at least one dose of treatment. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.

The events (reasons) for hospitalizations such as infection, transfusion, acute choleycystitis, allergic transfusion reaction, dyspnoea with right pleural effusion, febrile neutropenia, fever, for decitabine, Myelodysplastic Syndrome (MDS) hematuria, paronychia, pneumonia, heart failure, peri-anal abscess (PAA), pancytopenia,fluctuated neutropenia fever, right dorsal foot cellulitis, Right lower (Rt.Lw) lung pneumonia with impending respiratory (resp) failure, Serious adverse event (SAE)+schedule hospitalization for decitabine, septic shock and not available were reported.

Time frame: Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 days

Population: ITT population was defined as all participants who had received at least 1 dose of study medication.

Overall survival was defined as the time from the date of treatment start until death (whatever the cause). It was calculated from Kaplan-Meier estimates. Participants still alive were censored at the moment of last visit or contact.

Time frame: Start of treatment until disease progression or death (whichever occur first) or up to 736 days

Population: ITT population was defined as all participants who had received at least 1 dose of study medication.

Cytogenetic responses was assessed as per IWG 2006 criteria which define complete response as disappearance of the chromosomal abnormality without appearance of new ones and partial response as at least 50 percent reduction of the chromosomal abnormality.

Time frame: Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)

Population: ITT population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated at given time point.

Hematologic treatment response was assessed as per IWG 2006 criteria. This is measured in erythroid(HI-E), platelet(HI-P) and neutrophil(HI-N) lineages. HI-E response(pre-treatment\<11 gram per deciliter \[g/dl\]):hemoglobin increase by\>=1.5 g/dl and relevant reduction in RBC transfusions by 4 RBC transfusions/8week. HI-P response (pre-treatment\<100\*109/l):absolute increase of \>=30\*10\^9/l for participants starting with\>20\*10\^9/l and increase from \<20\*10\^9/l to\>20\*10\^9/l and by at least 100%. HI-N response (pre-treatment\<1.0\*10\^9/l): at least 100% increase and an absolute increase \>0.5\*10\^9/l.

Time frame: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)

Population: Intent-to-treat (ITT) population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluable for this outcome measure at given time point.

Transfusion requirements for both red blood cells as well as platelets were recorded for each participant.

Time frame: 8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days

Population: ITT population was defined as all participants who had received at least 1 dose of study medication.

Transfusion independent participants were calculated from all the participants who required transfusion in the duration of 8 weeks before first dose until disease progression or death or up to 736 days. Transfusion independence was defined as lack of requirement for transfusions for at least 8 weeks.

Time frame: 8 weeks before first dose and 736 days of treatment

Population: ITT population was defined as all participants who had received at least 1 dose of study medication.

The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1=Not at All' to 4=Very Much') and 2 questions: Q29 on overall health and Q30 on overall quality of life uses 7-point scale ranging from 1=Very Poor to 7=Excellent. Higher score indicates better quality of life.

Time frame: Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days)

Population: ITT population was defined as all participants who had received at least 1 dose of study medication.

Time to AML is defined as greater than 30 percent of blasts in bone marrow or the time to death was calculated from the date of treatment start until disease progression to AML or until death, which ever occurred first. Participants who were still alive and did not progress to AML were censored at the moment of last visit.

Time frame: Start of treatment until disease progression or death (whichever occur first) or up to 736 days

Population: ITT population was defined as all participants who had received at least 1 dose of study medication.