Table 2 Sensitivity analyses for the primary end point

From: Vedolizumab for the prevention of intestinal acute GVHD after allogeneic hematopoietic stem cell transplantation: a randomized phase 3 trial

Sensitivity analyses

Placebo (N = 165)

Vedolizumab (N = 168)

P valueb

HR (95% CI)c

Event, n (%)a

KM estimated survival, %

Event, n (%)a

KM estimated survival, %

Primary analysis

47 (28.5)

70.9

24 (14.3)

85.5

0.0009

0.45 (0.27–0.73)

Sensitivity 1: using day +187 windowd

48 (29.1)

70.2

24 (14.3)

85.5

0.0006

0.44 (0.27–0.71)

Sensitivity 2: by stratified log-rank teste

47 (28.5)

70.9

24 (14.3)

85.5

0.00096

0.45 (0.27–0.73)

Sensitivity 3: by competing risk analysisf

31 (18.8)

19.2 (cumulative incidence, %)

12 (7.1)

7.2 (cumulative incidence, %)

0.0012f

NA

Sensitivity 4: with corrected stratification informationg

47 (28.5)

70.9

24 (14.3)

85.5

0.0009

0.45 (0.27–0.73)

Sensitivity 5: with clinical stage 0 and stage unknown removedh

43 (26.1)

73.3

23 (13.7)

86.1

0.0029

0.47 (0.28–0.78)

  1. Prespecified sensitivity analyses for the primary end point of lower-GI aGVHD-free survival by day +180 after allo-HSCT, which included day +187 window, stratified log-rank test, competing risk analysis and corrected stratification information. Analyses included all randomized patients who received ≥1 dose of study treatment and received allo-HSCT. All statistical tests were two-sided.
  2. aNumber (%) of patients with an observed event/relapse/death (as applicable), whichever occurred first, from first study treatment dose (day −1) through day +180 or day +365. Full analysis set includes all randomized patients who received ≥1 dose of study treatment and received allo-HSCT.
  3. bP value for the comparison between vedolizumab and placebo was obtained by log-rank test, unless otherwise stated.
  4. cHR was obtained via a Cox proportional hazards model with treatment group, stratified by randomization strata: HLA match (7 of 8 or 8 of 8), conditioning regimen (MAC or RIC), ATG (with or without), unless otherwise stated.
  5. dSensitivity analysis 1, analysis of events occurring within a 7-day window at day +187 after allo-HSCT.
  6. eStratified log-rank test in sensitivity analysis 2 used to compare treatment groups stratified by randomization strata: HLA match (7 of 8 or 8 of 8), conditioning regimen (MAC or RIC), ATG (with or without).
  7. fCompeting risk is death in sensitivity analysis 3; P value for comparison of vedolizumab with placebo was obtained by Gray’s test.
  8. gSensitivity analysis 4 was performed using corrected stratification information for HLA match (7 of 8 or 8 of 8), conditioning regimen (MAC or RIC), ATG (with or without) collected after randomization.
  9. hSensitivity analysis 5 was an additional sensitivity analysis performed using an alternative primary end point definition excluding the investigator-indicated lower-GI aGVHD events with clinical stage as 0 or unknown in a post hoc fashion.
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