Table 1.

Example table showing the proportion of patients experiencing any grade level, and high-grade level (grade >3) of post-baseline symptomatic adverse events, based on clinician-report and patient-report, using the baseline grade subtraction method for the patient-report. Data are simulated based on observed patterns of clinician-reported and patient-reported grades for patients enrolled in actual clinical studies. Grades are based on Common Terminology Criteria for Adverse Events (CTCAE). This table is provided as illustrative of format only. No information regarding relationship between clinician-reporting and patient-reporting of adverse events should be drawn from this table.

Adverse Event		Any Grade		High Grade*		P-value†
		Arm A (N=100)	Arm B (N=100)	Arm A (N=100)	Arm B (N=100)
Anorexia	Clinician	43 (43%)	36 (36%)	3 (3%)	2 (2%)	0.39
	Patient	57 (57%)	40 (40%)	11 (11%)	8 (8%)	0.02
Constipation	Clinician	27 (27%)	23 (23%)	1 (1%)	--	0.62
	Patient	48 (48%)	41 (41%)	12 (12%)	7 (7%)	0.39
Diarrhea	Clinician	8 (8%)	14 (14%)	1 (1%)	--	0.26
	Patient	39 (39%)	12 (12%)	4 (4%)	--	<0.001
Nausea	Clinician	20 (20%)	7 (7%)	--	--	0.01
	Patient	66 (66%)	9 (9%)	9 (9%)	1 (1%)	<0.001
Sensory neuropathy	Clinician	54 (54%)	29 (29%)	7 (7%)	4 (4%)	<0.001
	Patient	59 (59%)	51 (51%)	3 (3%)	--	0.32

^*Grade >3 based on Common Terminology Criteria for Adverse Events (CTCAE).

^†Based on Fisher’s exact test comparing rate of grade >0 between arms.