Table 5: Heart Rate Change

Core analysis summary table for Change from Vehicle in Heart Rate on Dosing Day 3, presented by treatment group and time interval. This page links the generating program and the final output for submission-style review and traceability.

Endpoint definition

For each animal and time interval t on Dosing Day 3 (including baseline):

Change from Vehicle = (Value at Day 3, time t) − (Value at Vehicle Day 1, same time t).

Study-day phases

  • Phase 1: Hours 1–6 (six 1-hour subphases)
  • Phase 2: Hours 7–12 (six 1-hour subphases)
  • Phase 3: Hours 13–18 (six 1-hour subphases)
  • Phase 4: Hours 19–24 (six 1-hour subphases)

Analysis method

Within each phase, a repeated-measures ANCOVA (RANCOVA) is fit using PROC MIXED with: - Fixed effects: TRT, TIME, TRT×TIME
- Covariate: baseline Change from Vehicle
- Repeated effect: TIME
- Subject: SUBJID
- Covariance structure: selected by AICC across candidate structures

For each treatment group, H₀: Change from Vehicle = 0 is tested at α = 0.05 at each time interval.

Deliverables

Programming + Output

What you’ll find here

  • Purpose: Summarize Heart Rate Change from Vehicle across Day 3 time intervals, by treatment group
  • Traceability: Table shell/spec → Program → Output (review-ready)
  • Typical columns: LS mean (SE), 95% CI, t-value, p-value (vs 0), covariance structure (selected by AICC)
  • Typical display: phase-wise repeated-measures ANCOVA results aligned to SAP conventions