Stage 4: analysis (executed output)

Table 14.3.1.1 Overview of TEAEs

Executed: rtables 0.6.17 / tern 0.9.13

Synthetic data only: simulated for this worked example; not real trial data and not a regulatory deliverable.

Table 14.3.1.1 Overview of Treatment-Emergent Adverse Events

Safety set

Study SIMBE01 (synthetic)


	Test	Reference
	(N=40)	(N=39)
Participants with at least one TEAE	9 (22.5%)	10 (25.6%)
Total number of TEAEs	13	19
Participants with a related TEAE	8 (20.0%)	6 (15.4%)
Participants with a severe TEAE	0	1 (2.6%)
Participants with a serious TEAE	0	0
Participants with a TEAE leading to withdrawal	0	0
Participants with a TEAE leading to death	0	0

TEAE = adverse event with onset on or after the first dose, assigned to the treatment taken most recently before onset.

Each participant counts once per row; N = participants dosed with that treatment.

No total column: in a crossover a participant contributes to both columns. MedDRA v28.1 (synthetic coding).

Synthetic data; not a regulatory deliverable.

Files: t_14_3_1_1.rtf (RTF from formatters::export_as_rtf()), t_14_3_1_1.csv (the displayed cells). Program: study/04_analysis/03_tlf.R.