Table 7

Time course summary of adverse events

Interval^*	1	1	2	2	3	3	4	4	5	5	6	6	7	7	8	8	9	9	10	10	11	11	12	12	Total	Total
	E^†	P^‡	E	P	E	P	E	P	E	P	E	P	E	P	E	P	E	P	E	P	E	P	E	P	E	P (%)
Investigational(N = 280)
Any adverse event	29	25	173	80	179	89	241	117	246	115	401	146	312	116	328	97	218	79	300	89	222	71	125	62	2774	271 (96.8)
Anatomical/technical difficulty	2	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	3	3 (1.1)
Cancer	0	0	1	1	0	0	0	0	1	1	3	2	0	0	4	2	0	0	2	2	0	0	1	1	12	6 (2.1)
Cardiac disorders	0	0	2	1	2	1	0	0	2	2	5	4	11	8	6	4	8	7	11	6	8	7	6	6	61	39 (13.9)
Death	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	2	0	0	0	0	2	2 (0.7)
Dysphagia/dysphonia	1	1	15	12	4	4	5	5	4	3	0	0	2	2	5	5	1	1	0	0	0	0	0	0	37	31 (11.1)
Gastrointestinal	2	1	8	6	1	1	3	3	3	3	20	13	18	9	19	9	19	11	23	14	20	13	4	3	140	64 (22.9)
Heterotopic ossification	0	0	2	2	6	5	2	2	4	3	3	3	6	6	5	5	5	5	6	6	5	4	8	7	52	44 (15.7)
Implant events	6	6	1	1	2	2	2	2	0	0	0	0	4	4	1	1	1	1	4	4	0	0	1	1	22	20 (7.1)
Infection	1	1	5	4	5	5	6	5	10	9	14	11	11	10	18	16	6	5	23	12	9	8	9	7	117	61 (21.8)
Neck and/or arm pain	3	2	35	23	54	41	70	49	52	37	76	54	49	29	39	26	25	20	37	25	29	19	14	10	483	186 (66.4)
Neurological	2	2	14	11	23	16	36	30	24	20	69	48	31	20	25	18	15	12	20	13	23	13	8	7	290	147 (52.5)
Non-union	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	1	1	1	1	0	0	0	0	3	2 (0.7)
Other	4	4	19	15	14	12	23	14	29	22	56	40	29	22	40	22	38	25	45	32	45	27	25	17	367	142 (50.7)
Other pain	4	4	19	19	33	28	48	38	53	40	69	48	48	32	64	46	50	33	52	36	25	19	21	17	486	181 (64.6)
Respiratory	0	0	8	6	0	0	1	1	11	8	1	1	13	11	3	3	1	1	13	10	12	7	5	4	68	46 (16.4)
Spinal event	0	0	22	13	25	14	26	16	26	20	52	30	44	18	68	27	16	10	25	15	24	10	13	9	341	127 (45.4)
Trauma	0	0	6	6	5	5	13	12	12	12	20	19	20	18	18	17	14	11	15	13	11	9	9	9	143	106 (37.9)
Urogenital	1	1	1	1	2	2	1	1	8	6	11	8	16	12	7	6	14	8	14	11	7	6	1	1	83	51 (18.2)
Vascular	3	3	1	1	1	1	1	1	2	2	0	0	5	4	4	3	4	4	5	3	4	3	0	0	30	24 (8.6)
Wound (non-infectious)	0	0	14	10	2	2	4	3	4	1	2	2	5	4	2	2	0	0	1	1	0	0	0	0	34	23 (8.2)
Control (N = 265)
Any adverse event	34	19	119	66	97	47	211	94	143	79	280	104	341	117	235	82	256	82	251	88	153	53	116	51	2236	232 (87.5)
Anatomical/technical difficulty	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0 (0.0)
Cancer	0	0	1	1	0	0	0	0	0	0	0	0	1	1	1	1	0	0	1	1	1	1	0	0	5	5 (1.9)
Cardiac disorders	0	0	2	2	1	1	2	2	3	2	3	3	9	9	7	4	5	4	5	5	6	6	3	3	46	37 (14.0)
Death	0	0	0	0	0	0	1	1	0	0	1	1	1	1	0	0	2	2	0	0	0	0	0	0	5	5 (1.9)
Dysphagia/dysphonia	5	4	11	11	4	4	3	3	0	0	1	1	0	0	0	0	3	2	4	4	0	0	0	0	31	26 (9.8)
Gastrointestinal	7	4	7	5	3	2	4	4	3	3	21	12	24	13	8	7	16	11	12	8	9	5	6	5	120	64 (24.2)
Heterotopic ossification	0	0	1	1	4	1	2	2	1	1	3	3	11	9	3	3	8	8	5	4	3	3	3	3	44	34 (12.8)
Implant events	0	0	1	1	1	1	0	0	0	0	2	2	1	1	1	1	0	0	4	3	1	1	0	0	11	9 (3.4)
Infection	2	1	3	3	5	5	2	2	1	1	10	9	14	10	10	9	6	6	4	4	10	9	11	8	78	49 (18.5)
Neck and/or arm pain	2	1	18	14	19	15	49	37	42	33	55	44	41	28	28	19	36	24	23	19	5	3	24	18	342	156 (58.9)
Neurological	6	5	24	20	18	11	36	24	17	13	57	34	61	35	42	29	28	19	30	24	11	11	18	12	348	144 (54.3)
Non-union	0	0	0	0	3	3	4	4	9	9	9	9	9	9	1	1	0	0	2	2	0	0	1	1	38	35 (13.2)
Other	3	2	14	12	13	10	17	13	10	10	20	14	54	31	26	19	31	24	43	27	31	19	13	12	275	123 (46.4)
Other pain	6	4	19	16	10	10	44	33	28	25	58	40	60	43	49	34	45	33	50	33	30	24	19	15	418	167 (63.0)
Respiratory	0	0	4	3	4	2	1	1	5	4	1	1	8	7	4	4	2	2	10	8	8	5	3	2	50	32 (12.1)
Spinal event	0	0	8	6	6	5	30	15	15	9	22	12	33	17	31	16	47	25	30	18	14	8	6	5	242	106 (40.0)
Trauma	0	0	2	2	4	4	12	11	5	5	9	8	12	10	15	14	20	20	15	14	15	13	7	7	116	79 (29.8)
Urogenital	0	0	0	0	0	0	1	1	3	3	5	4	2	2	6	4	5	3	11	7	7	5	1	1	41	26 (9.8)
Vascular	1	1	0	0	0	0	1	1	0	0	1	1	0	0	1	1	2	2	1	1	1	1	0	0	8	8 (3.0)
Wound (non-infectious)	2	2	4	4	2	2	2	2	1	1	2	2	0	0	2	2	0	0	1	1	1	1	1	1	18	18 (6.8)

↵* Intervals: (1) Operative; (2) 1 day; (3) 1.5 months; (4) 3 months; (5) 6 months;(6) 12 months; (7) 24 months; (8) 36 months; (9) 48 months; (10) 60 months; (11) 72 months; (12) 84 months.
↵† E = Number of events
↵‡ P Number of patients.