A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia

Table 6 Treatment-emergent serious adverse events based on exploratory analysis of the safety data

	Patients who completed the study on 150 mg eq. throughout			Patients who did not complete the study on 150 mg eq. throughout
	Group A (N = 100)	Group B (N = 4)	Total (N = 104)	Group C (N = 86)	Group D (N = 22)	Total (N = 108)
Total no. patients with serious TEAEs	5 (5.0)	0	5 (4.8)	24 (27.9)	4 (18.2)	28 (25.9)
Schizophrenia	3 (3.0)	0	3 (2.9)	7 (8.1)	1 (4.5)	8 (7.4)
Psychotic disorder	1 (1.0)	0	1 (1.0)	5 (5.8)	0	5 (4.6)
Anxiety	1 (1.0)	0	1 (1.0)	1 (1.2)	0	1 (0.9)
Hallucination, auditory	1 (1.0)	0	1 (1.0)	1 (1.2)	0	1 (0.9)
Hallucination, tactile	1 (1.0)	0	1 (1.0)	0	0	0
Agitation	0	0	0	5 (5.8)	0	5 (4.6)
Insomnia	0	0	0	3 (3.5)	0	3 (2.8)
Abnormal behaviour	0	0	0	1 (1.2)	0	1 (0.9)
Aggression	0	0	0	1 (1.2)	0	1 (0.9)
Alcohol abuse	0	0	0	0	1 (4.5)	1 (0.9)
Delusion	0	0	0	0	1 (4.5)	1 (0.9)
Hallucination	0	0	0	1 (1.2)	0	1 (0.9)
Paranoia	0	0	0	1 (1.2)	0	1 (0.9)
Psychiatric decompensation	0	0	0	1 (1.2)	0	1 (0.9)
Schizophrenia, paranoid type	0	0	0	1 (1.2)	0	1 (0.9)
Tremor	0	0	0	2 (2.3)	0	2 (1.9)
Akathisia	0	0	0	1 (1.2)	0	1 (0.9)
Convulsion	0	0	0	1 (1.2)	0	1 (0.9)
Dystonia	0	0	0	0	1 (4.5)	1 (0.9)
Parkinsonism	0	0	0	0	1 (4.5)	1 (0.9)
Salivary hypersecretion	0	0	0	2 (2.3)	0	2 (1.9)
Gastrooesophageal reflux disease	0	0	0	1 (1.2)	0	1 (0.9)
Muscle rigidity	0	0	0	2 (2.3)	0	2 (1.9)
Bradycardia	0	0	0	1 (1.2)	0	1 (0.9)
Irritability	0	0	0	1 (1.2)	0	1 (0.9)
Hypochloraemia	0	0	0	1 (1.2)	0	1 (0.9)
Hyponatraemia	0	0	0	1 (1.2)	0	1 (0.9)
Pneumonia	0	0	0	0	1 (4.5)	1 (0.9)

Note: Group A consists of all patients who completed the study on 150 mg eq. and stayed on intensive PK sampling throughout; and Group B consists of all patients who completed the study on 150 mg but were not on intensive PK sampling. Group C consists of patients who withdrew early while on 150 mg eq. and intensive PK sampling. Group D consists of patients who completed the trial while on flexible dose and switched to non-intensive PK sampling (N = 9); patients who withdrew from the trial while on 150 mg eq. and switched to non-intensive sampling (N = 3); and patients who withdrew from the trial while on flexible dose and switched to non-intensive sampling (N = 10)

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