Table 2.

Concordance of ADRs by patient interview compared to clinician documentation

ADR	ADR from interview N (%)	ADR from medical record N (%)	Kappa (95% CI)	Gwet’s AC 1	Overall Percent Agreement*	P-value from McNemar’s Test
Insomnia	83 (68.6%)	2 (1.7%)	0.02 (0.05, −0.02)	−0.23	33.1%	<0.001
PN	78 (64.5%)	22 (18.2%)	0.02 (0.13, −0.09)	−0.12	42.2%	<0.001
Confusion	74 (61.2%)	5 (4.1%)	−0.001 (0.06, −0.06)	−0.08	39.7%	<0.001
N/V	69 (57%)	22 (18.2%)	0.07 (0.20, −0.05)	0.05	49.6%	<0.001
Depression	69 (57%)	0	0	0.04
Rash	65 (53.7%)	19 (15.7%)	0.09 (0.21, −0.04)	0.12	52.1%	<0.001
Dizziness	65 (53.7%)	10 (8.3%)	0.11 (0.21, 0.02)	0.11	52.9%	<0.001
Gastritis	64 (52.9%)	8 (6.6%)	−0.01 (0.08, −0.09)	0.09	47.1%	<0.001
Myalgia	61 (50.4%)	3 (2.5%)	0.02 (0.07, −0.04)	0.19	50.4%	<0.001
Anorexia	55 (45.5%)	6 (5%)	0.08 (0.17, 0.00)	0.32	57.9%	<0.001
Arthralgia	53 (43.8%)	14 (11.6%)	0.10 (0.23, −0.02)	0.32	59.5%	<0.001
Vision	52 (43%)	13 (10.7%)	0.2 (0.32, 0.08)	0.41	64.5%	<0.001
Tinnitus	50 (41.3%)	9 (7.4%)	0.10 (0.21, −0.01)	0.42	62.8%	<0.001
Anxiety	50 (41.3%)	0	0	0.39
Fatigue	49 (40.5%)	1 (0.8%)	−0.02 (0.02, −0.06)	0.39	58.7%	<0.001
Hearing	39 (32.2%)	32 (26.4%)	0.23 (0.40, 0.05)	0.45	67.8%	0.34
Headache	34 (28.1%)	4 (3.3%)	0.05 (0.15, −0.05)	0.62	71.9%	<0.001
Diarrhea	31 (25.6%)	1 (0.8%)	0.05 (0.10, −0.01)	0.68	75.2%	<0.001

^*Overall percent agreement was calculated by Stata and defined as the number of concordant counts (ADR present in both sources or absent in both sources) divided by the total sample size and expressed as a percent