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edelarua committed Oct 10, 2024
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32 changes: 16 additions & 16 deletions package/tests/testthat/_snaps/development/tables-ADA-adat01.md
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Baseline Prevalence and Incidence of Treatment Emergent ADA
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A: Drug X C: Combination <Missing> B: Placebo All Drug X
(N=134) (N=132) (N=0) (N=134) (N=266)
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Baseline Prevalence of ADAs
Baseline evaluable patients 134 132 0 0 266
Patient with a positive sample at baseline 63 (47.0%) 64 (48.5%) 0 0 127 (47.7%)
Patient with no positive samples at baseline 71 68 0 0 139
Incidence of Treatment Emergent ADAs
Post-baseline evaluable patients 134 132 0 0 266
Patient positive for Treatment Emergent ADA 0 0 0 0 0
Treatment-induced ADA 0 0 0 0 0
Treatment-enhanced ADA 0 0 0 0 0
Patient negative for Treatment Emergent ADA 0 0 0 0 0
Treatment unaffected 0 0 0 0 0
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A: Drug X C: Combination All Drug X B: Placebo All Patients
(N=134) (N=132) (N=266) (N=134) (N=400)
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Baseline Prevalence of ADAs
Baseline evaluable patients 134 132 266 0 266
Patient with a positive sample at baseline 63 (47.0%) 64 (48.5%) 127 (47.7%) 0 127 (47.7%)
Patient with no positive samples at baseline 71 68 139 0 139
Incidence of Treatment Emergent ADAs
Post-baseline evaluable patients 134 132 266 0 266
Patient positive for Treatment Emergent ADA 0 0 0 0 0
Treatment-induced ADA 0 0 0 0 0
Treatment-enhanced ADA 0 0 0 0 0
Patient negative for Treatment Emergent ADA 0 0 0 0 0
Treatment unaffected 0 0 0 0 0
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ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic Antibodies) Baseline evaluable patient = a patient with an ADA assay result from a baseline sample(s)
Post-baseline evaluable patient = a patient with an ADA assay result from at least one post-baseline sample Number of patients positive for Treatment Emergent
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36 changes: 18 additions & 18 deletions package/tests/testthat/_snaps/development/tables-ADA-adat04a.md
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Baseline Prevalence and Incidence of Treatment Emergent NAbs
Protocol: A: Drug X Antibody
—————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
A: Drug X C: Combination <Missing> B: Placebo All Drug X
(N=134) (N=132) (N=0) (N=134) (N=266)
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Baseline Prevalence of NAbs
Baseline evaluable patients for ADA 134 132 0 0 266
Patients with a positive ADA sample at baseline 63 64 0 0 127
Patients with a positive NAb sample at baseline 0 0 0 0 0
Patient with no positive NAb samples at baseline 0 0 0 0 0
Incidence of Treatment Emergent NAbs
Post-baseline evaluable patients for ADA 134 132 0 0 266
Patients positive for ADA 66 59 0 0 125
Patients positive for Treatment Emergent NAb 0 0 0 0 0
Treatment-induced NAb 0 0 0 0 0
Treatment-enhanced NAb 0 0 0 0 0
Patients negative for NAb 0 0 0 0 0
Treatment unaffected 0 0 0 0 0
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
A: Drug X C: Combination All Drug X B: Placebo All Patients
(N=134) (N=132) (N=266) (N=134) (N=400)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Baseline Prevalence of NAbs
Baseline evaluable patients for ADA 134 132 266 0 266
Patients with a positive ADA sample at baseline 63 64 127 0 127
Patients with a positive NAb sample at baseline 0 0 0 0 0
Patient with no positive NAb samples at baseline 0 0 0 0 0
Incidence of Treatment Emergent NAbs
Post-baseline evaluable patients for ADA 134 132 266 0 266
Patients positive for ADA 66 59 125 0 125
Patients positive for Treatment Emergent NAb 0 0 0 0 0
Treatment-induced NAb 0 0 0 0 0
Treatment-enhanced NAb 0 0 0 0 0
Patients negative for NAb 0 0 0 0 0
Treatment unaffected 0 0 0 0 0
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NAb = Neutralizing Antibodies ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic Antibodies) Baseline evaluable patient for ADA = a patient with an ADA assay result from a baseline sample(s)
Baseline evaluable patient for NAb = a patient with a NAb assay result from a baseline sample(s)
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30 changes: 15 additions & 15 deletions package/tests/testthat/_snaps/development/tables-ADA-adat04b.md
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Baseline Prevalence and Incidence of Neutralizing Antibodies (NAbs)
Protocol: A: Drug X Antibody
—————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
A: Drug X C: Combination <Missing> B: Placebo All Drug X
(N=134) (N=132) (N=0) (N=134) (N=266)
—————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Baseline Prevalence of NAbs
Baseline evaluable patients for ADA 134 132 0 0 266
Patients with a positive ADA sample at baseline 63 64 0 0 127
Patients with a positive NAb sample at baseline 0 0 0 0 0
Patients with no positive NAb sample at baseline 0 0 0 0 0
Incidence of NAbs
Post-baseline evaluable patients for ADA 134 132 0 0 266
Patients positive for ADA 66 59 0 0 125
Patients positive for NAb 0 0 0 0 0
Patients negative for NAb 134 132 0 0 266
—————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
A: Drug X C: Combination All Drug X B: Placebo All Patients
(N=134) (N=132) (N=266) (N=134) (N=400)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Baseline Prevalence of NAbs
Baseline evaluable patients for ADA 134 132 266 0 266
Patients with a positive ADA sample at baseline 63 64 127 0 127
Patients with a positive NAb sample at baseline 0 0 0 0 0
Patients with no positive NAb sample at baseline 0 0 0 0 0
Incidence of NAbs
Post-baseline evaluable patients for ADA 134 132 266 0 266
Patients positive for ADA 66 59 125 0 125
Patients positive for NAb 0 0 0 0 0
Patients negative for NAb 134 132 266 0 266
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
NAb = Neutralizing Antibodies ADA = Anti-Drug Antibodies (is also referred to as ATA, or Anti-Therapeutic Antibodies) Baseline evaluable patient for ADA = a patient with an ADA assay result from a baseline sample(s) Baseline evaluable patient for NAb = a patient with a NAb assay result from a baseline sample(s) Post-baseline evaluable patient for ADA = a patient with an ADA assay result from at least one post-baseline sample Post-baseline evaluable patient for NAb = a patient with a NAb assay result from at least one post-baseline sample Number of patients positive for ADA = the number of post-baseline evaluable patients for ADA determined to have Treatment Emergent ADA during the study period.
Number of patients positive for NAb = the number (and percentage) of post-baseline evaluable patients for ADA determined to have at least one positive post-baseline NAb result during the study period. Number of patients negative for NAb = number of post-baseline evaluable patients with all negative post-baseline NAb results.
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4 changes: 2 additions & 2 deletions package/tests/testthat/_snaps/development/tables-efficacy-mmrmt01.md
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Difference in Adjusted Means (SE) 0.759 (0.973) -0.325 (0.976)
95% CI (-1.155, 2.672) (-2.243, 1.593)
Relative Increase (%) 21.8% -9.3%
p-value (MMRM) 0.4362 0.7394
p-value (MMRM) 0.4362 0.7393
WEEK 2 DAY 15
n 134 134 132
Adjusted Mean (SE) 9.135 (0.768) 9.018 (0.767) 8.509 (0.773)
95% CI (7.626, 10.644) (7.510, 10.527) (6.991, 10.028)
Difference in Adjusted Means (SE) -0.117 (1.087) -0.626 (1.090)
95% CI (-2.253, 2.020) (-2.768, 1.517)
Relative Increase (%) -1.3% -6.8%
p-value (MMRM) 0.9146 0.5662
p-value (MMRM) 0.9147 0.5662
WEEK 3 DAY 22
n 134 134 132
Adjusted Mean (SE) 13.547 (0.871) 16.014 (0.871) 15.789 (0.877)
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