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Trial · NCT03347396

Results by group439

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Part A: Percentage of Participants With Response to TreatmentBIVV00954.295% Confidence Interval 32.8 to 74.4percentage of participants
Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)BIVV009 6.5 gTEAEs16Participants
Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)BIVV009 7.5 gTEAEs6Participants
Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)BIVV009 6.5 gTESAEs10Participants
Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)BIVV009 7.5 gTESAEs2Participants
Part A: Mean Change From Baseline in Bilirubin Levels at the Treatment Assessment TimepointBIVV009-38.1895% Confidence Interval -42.52 to -33.84micromoles per Liter (mcmol/L)
Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Treatment Assessment TimepointBIVV00910.8595% Confidence Interval 8.00 to 13.70score on a scale
Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment TimepointBIVV009-126.9595% Confidence Interval -218.47 to -35.42units per liter
Part A: Number of Blood Transfusions Per ParticipantBIVV0090.9Standard Deviation 2.75blood transfusions per participant
Part A: Number of Blood Units Transfused Per ParticipantBIVV0095.8Standard Deviation 8.47blood units transfused per participant
Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment TimepointBIVV0092.6095% Confidence Interval 0.74 to 4.46g/dL
Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time PointsBIVV009Week 272.76Standard Deviation 2.20g/dL
Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time PointsBIVV009Week 292.77Standard Deviation 2.20g/dL
Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time PointsBIVV009Week 312.74Standard Deviation 1.96g/dL
Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time PointsBIVV009Week 332.87Standard Deviation 1.97g/dL
Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time PointsBIVV009Week 352.82Standard Deviation 2.10g/dL
Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time PointsBIVV009Week 372.71Standard Deviation 2.08g/dL
Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time PointsBIVV009Week 392.72Standard Deviation 2.26g/dL
Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time PointsBIVV009Week 412.76Standard Deviation 2.24g/dL
Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time PointsBIVV009Week 432.73Standard Deviation 2.06g/dL

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.

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