Trial Outcomes & Findings for Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-year Period in Patients With Schizophrenia (NCT NCT00299702)

Last Updated: 2011-12-30

Results Overview

Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

355 participants

Primary outcome timeframe

Day 1 to relapse

Results posted on

2011-12-30

Participant Flow

The first patient in was on February 28, 2006; last patient out was on January 26, 2009. Enrollment occurred across multiple sites in the United States, Argentina, Chile, and India and patients were enrolled from outpatient psychiatric clinics associated with private medical practices, private clinical trial sites, and academic medical centers.

A Screening Visit (maximum of 14 days) prior to the Treatment Phase. Baseline included psychiatric exam, lab, ECG, and schizophrenia symptom rating scale. Subjects were permitted to remain on previous psychotropic medications (i.e., antipsychotic, antidepressant, mood stabilizer, anxiolytics) up to the first 4 weeks of the Treatment Phase.

Participant milestones

Participant milestones
Measure	Risperdal Consta 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks	Abilify 10-30 mg once daily oral for 104 weeks
Overall Study STARTED	179	176
Overall Study COMPLETED	126	126
Overall Study NOT COMPLETED	53	50

Reasons for withdrawal

Reasons for withdrawal
Measure	Risperdal Consta 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks	Abilify 10-30 mg once daily oral for 104 weeks
Overall Study Death	1	0
Overall Study Adverse Event	0	4
Overall Study Lost to Follow-up	18	10
Overall Study Withdrawal by Subject	25	23
Overall Study Pregnancy	0	1
Overall Study Insufficient Response	4	3
Overall Study Admin issues, sponsor decision, etc.	5	9

Baseline Characteristics

Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-year Period in Patients With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risperdal Consta n=179 Participants 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks	Abilify n=176 Participants 10-30 mg once daily oral for 104 weeks	Total n=355 Participants Total of all reporting groups
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	177 Participants n=5 Participants	173 Participants n=7 Participants	350 Participants n=5 Participants
Age Continuous	38.3 years STANDARD_DEVIATION 11.66 • n=5 Participants	37.8 years STANDARD_DEVIATION 11.49 • n=7 Participants	38 years STANDARD_DEVIATION 11.56 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	70 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	106 Participants n=7 Participants	212 Participants n=5 Participants
Region of Enrollment India	91 participants n=5 Participants	91 participants n=7 Participants	182 participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	52 participants n=7 Participants	103 participants n=5 Participants
Region of Enrollment South America	37 participants n=5 Participants	33 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to relapse

Population: explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.

Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board.

Outcome measures

Outcome measures
Measure	Risperdal Consta n=177 Participants 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks	Abilify n=172 Participants 10-30 mg once daily oral for 104 weeks
Time to Relapse	131 days Interval 100.0 to 197.0	113 days Interval 99.0 to 169.0

PRIMARY outcome

Timeframe: Day 1 to last PANSS measurement

Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6).

Outcome measures

Outcome measures
Measure	Risperdal Consta n=179 Participants 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks	Abilify n=176 Participants 10-30 mg once daily oral for 104 weeks
Time in Remission	373.5 days Standard Deviation 282.6	356.7 days Standard Deviation 291.99

Adverse Events

RISPERDAL CONSTA

Serious events: 31 serious events

Other events: 151 other events

Deaths: 0 deaths

Abilify

Serious events: 35 serious events

Other events: 141 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Therapeutic Area Lead

Ortho-McNeil, Inc. N America Pharm CNS/IM

Phone: 609-730-3693

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	RISPERDAL CONSTA n=179 participants at risk 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks	Abilify n=176 participants at risk 10-30 mg once daily oral for 104 weeks
Blood and lymphatic system disorders ANAEMIA	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Endocrine disorders GOITRE	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders ANAL FISSURE	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders DIARRHOEA	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders IRRITABLE BOWEL SYNDROME	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders MELAENA	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders VOMITING	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
General disorders DEATH	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
General disorders PYREXIA	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Infections and infestations CELLULITIS	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Infections and infestations PNEUMONIA	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Injury, poisoning and procedural complications MULTIPLE DRUG OVERDOSE ACCIDENTAL	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Metabolism and nutrition disorders DIABETIC KETOACIDOSIS	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEIOMYOMA	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Nervous system disorders AKATHISIA	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Nervous system disorders CONVULSION	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Nervous system disorders SYNCOPE	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders PSYCHOTIC DISORDER	6.7% 12/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	6.2% 11/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders SCHIZOPHRENIA	3.9% 7/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	6.8% 12/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders SUICIDAL IDEATION	1.1% 2/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders AGGRESSION	1.1% 2/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders DEPRESSION SUICIDAL	1.1% 2/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders AFFECT LABILITY	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders ALCOHOLISM	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders ANXIETY	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders COMPLETED SUICIDE	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders DRUG DEPENDENCE	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders HOMICIDAL IDEATION	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders MANIA	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders MENTAL STATUS CHANGES	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders SUICIDE ATTEMPT	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.56% 1/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.

Measure	RISPERDAL CONSTA n=179 participants at risk 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks	Abilify n=176 participants at risk 10-30 mg once daily oral for 104 weeks
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	3.9% 7/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	10.2% 18/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Infections and infestations INFLUENZA	6.1% 11/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	4.0% 7/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Investigations WEIGHT INCREASED	8.4% 15/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	8.5% 15/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Metabolism and nutrition disorders DECREASED APPETITE	16.2% 29/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	9.1% 16/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	7.8% 14/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	8.0% 14/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Endocrine disorders HYPERPROLACTINAEMIA	5.0% 9/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.00% 0/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders DIARRHOEA	6.7% 12/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	10.8% 19/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders VOMITING	10.1% 18/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	7.4% 13/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders NAUSEA	8.9% 16/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	6.2% 11/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders CONSTIPATION	7.8% 14/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	6.8% 12/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	3.4% 6/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	6.2% 11/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Gastrointestinal disorders SALIVARY HYPERSECRETION	3.9% 7/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	5.1% 9/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
General disorders PYREXIA	14.5% 26/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	11.9% 21/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
General disorders FATIGUE	5.6% 10/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	9.7% 17/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
General disorders ASTHENIA	3.9% 7/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	8.0% 14/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
General disorders INJECTION SITE PAIN	5.0% 9/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	0.57% 1/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Infections and infestations NASOPHARYNGITIS	10.1% 18/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	9.1% 16/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Musculoskeletal and connective tissue disorders BACK PAIN	6.7% 12/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	8.0% 14/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Musculoskeletal and connective tissue disorders ARTHRALGIA	6.7% 12/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	6.8% 12/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Nervous system disorders TREMOR	21.8% 39/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	22.7% 40/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Nervous system disorders HEADACHE	16.8% 30/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	15.3% 27/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Nervous system disorders AKATHISIA	11.2% 20/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	11.4% 20/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Nervous system disorders DIZZINESS	14.0% 25/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	7.4% 13/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Nervous system disorders HYPERSOMNIA	6.1% 11/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	5.7% 10/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Nervous system disorders SOMNOLENCE	6.7% 12/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	4.0% 7/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Nervous system disorders SEDATION	5.6% 10/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	3.4% 6/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders INSOMNIA	26.3% 47/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	29.0% 51/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders PSYCHOTIC DISORDER	16.8% 30/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	17.0% 30/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders ANXIETY	17.9% 32/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	14.8% 26/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders SCHIZOPHRENIA	14.0% 25/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	11.9% 21/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders DEPRESSION	13.4% 24/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	8.5% 15/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders RESTLESSNESS	6.1% 11/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	2.8% 5/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Psychiatric disorders SLEEP DISORDER	3.9% 7/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	5.1% 9/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
Respiratory, thoracic and mediastinal disorders COUGH	9.5% 17/179 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.	6.8% 12/176 • Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.