Trial · NCT02993783
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Overall Response (Partial Response [PR]+Very Good Partial Response [VGPR]+Complete Response [CR]) at Day 28 | Day 28 | CR is defined as the resolution of all signs and symptoms of acute graft-versus-host-disease (GvHD). VGPR is defined as resolution of the signs and symptoms of the GvHD: 1) Skin: no rash, or residual erythematous rash involving \<25% of the body surface, without bullae (excluding residual faint erythema and hyperpigmentation). 2) Liver: total serum bilirubin concentration \<2 mg/dL or \<25% of baseline at enrollment. 3) Gut: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of 1 GvHD stage in 1 or more organs without progression in any organ. |
| Primary | Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28 | From first dose up to Day 28 | An Adverse Event (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. |
| Secondary | Percentage of Participants Who Died in the Absence of Primary Malignancy Relapse After Allo-HSCT at Month 6 | Month 6 | |
| Secondary | Percentage of Participants With Acute GvHD Complete Response (CR) at Day 28 | Day 28 | CR is defined as the resolution of all signs and symptoms of acute GvHD. |
| Secondary | Percentage of Participants With Intestinal Overall Response at Day 28 | Day 28 | Symptoms of acute intestinal GvHD were measured using the BMT CTN-modified International Bone Marrow Transplant Registry Database (IBMTR) index. Intestinal overall response is either CR, VGPR or PR for intestine only. CR is defined as the resolution of all signs and symptoms of GvHD. VGPR is defined as resolution of the majority of signs and symptoms of intestinal GvHD: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of intestinal GvHD by at least 1 stage. |
| Secondary | Kaplan-Meier Estimate of Percentage of Participants Achieving Survival at Months 6 and 12 | Months 6 and 12 | The Kaplan-Meier estimate reports the percentage of participants surviving at Months 6 and 12. |
| Secondary | Percentage of Participants Alive Without GvHD or Primary Malignancy Relapse at Months 6 and 12 | Months 6 and 12 | |
| Secondary | Total Dose of Steroids Administered | From first dose of study drug up to Months 6 and 12 | Total Steroids administered in mg/kg/day of methylprednisolone or equivalent |
| Secondary | Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | From first dose of study drug to 18 weeks after last dose (Up to 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 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. |
| Secondary | Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Week 32 | From first dose of study drug to 18 weeks after last dose (Up to 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. |
| Secondary | Number of Participants With Markedly Abnormal Laboratory Parameters Values | From Baseline up to last dose of study drug (Day 99) | 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). |
| Secondary | Number of Participants With Markedly Abnormal Vital Signs | From Baseline up to last dose of study drug (Day 99) | 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. |
| Secondary | Ctrough: Trough Serum Concentrations of Vedolizumab | Day 99 (pre-dose) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02993783/registered