A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

Kaplan-Meier Estimate of Percentage of Participants Achieving Survival at Months 6 and 12

The Kaplan-Meier estimate reports the percentage of participants surviving at Months 6 and 12.

Time frame: Months 6 and 12

Percentage of Participants Alive Without GvHD or Primary Malignancy Relapse at Months 6 and 12

Time frame: Months 6 and 12

Total Dose of Steroids Administered

Total Steroids administered in mg/kg/day of methylprednisolone or equivalent

Time frame: From first dose of study drug up to Months 6 and 12

Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

Time frame: From first dose of study drug to 18 weeks after last dose (Up to Week 32)

Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Week 32

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Time frame: From first dose of study drug to 18 weeks after last dose (Up to Week 32)

Number of Participants With Markedly Abnormal Laboratory Parameters Values

Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)\>3.0 U/L\*upper limit of normal(ULN),albumin\<25 g/L\*lower limit of normal(LLN),alkaline phosphatase \>3.0 U/L\*ULN,aspartate aminotransferase \>3.0 U/L\*ULN,bilirubin \>2 umol/L\*ULN,blood urea nitrogen(BUN) \>10.7 mmol/L,calcium \<1.75 mmol/L, \>2.88 mmol/L,chloride \<75 mmol/L, \>126 mmol/L,creatinine \>177umol/L,gamma glutamyl transferase (GGT) \>3 U/L\*ULN,glucose \<2.8 mmol/L, \>19.4 mmol/L,phosphate \<0.52 mmol/L, \>2.10 mmol/L,potassium\<3 mmol/L, \>6 mmol/L,sodium \<130 mmol/L, \>150 mmol/L,basophils \>3(10\^9/L)\*ULN,eosinophils \>2(10\^9/L)\*ULN,hematocrit (%) \<0.8\*LLN, \>1.2\*ULN,hemoglobin \<0.8 g/L\*LLN, \>1.2 g/L\*ULN,leukocytes \<0.5 (10\^9/L)\*LLN, \>1.5 (10\^9/L)\*ULN,lymphocytes \<0.5 (10\^9/L)\*LLN, \>1.5(10\^9/L)\*ULN,monocytes \>2 (10\^9/L)\*ULN,neutrophils \<0.5(10\^9/L)\*LLN, \>1.5 (10\^9/L)\*ULN,platelets \<75(10\^9/L), \>600(10\^9/L).

Time frame: From Baseline up to last dose of study drug (Day 99)

Number of Participants With Markedly Abnormal Vital Signs

Vital signs included heart rate, respiratory rate, systolic and diastolic blood pressure, temperature and weight. The vital sign values outside the range: systolic blood pressure (SBP) \<85 mmHg and change from Baseline (BL) \<=-20 mmHg, \>180 mmHg and change from Baseline \>=20 mmHg,diastolic blood pressure (DBP) \<50 mmHg and change from Baseline \<=-15 mmHg, \>110 mmHg and change from Baseline \>=15 mmHg, heart rate \<50 beats per minute (bpm),\>120 beats per minute, temperature \<35.6 Degree C, \>37.7 Degree C and weight change from Baseline \<=-7 % and weight change from Baseline \>=7 % assessed during treatment period were considered markedly abnormal.

Time frame: From Baseline up to last dose of study drug (Day 99)

Ctrough: Trough Serum Concentrations of Vedolizumab

Time frame: Day 99 (pre-dose)