Trial Outcomes & Findings for A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis (NCT NCT01174004)

Last Updated: 2014-03-26

Results Overview

Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement. Analysis Method: Mixed Model Repeated Measures (MMRM)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

199 participants

Primary outcome timeframe

Each study visit (i.e. Days 1, 15, 29 and 43)

Results posted on

2014-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo tablet, once daily by mouth, 6 weeks	Pimavanserin 40 mg Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Overall Study STARTED	94	105
Overall Study COMPLETED	87	89
Overall Study NOT COMPLETED	7	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo tablet, once daily by mouth, 6 weeks	Pimavanserin 40 mg Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Overall Study Adverse Event	2	10
Overall Study Withdrawal by Subject	2	3
Overall Study At Discretion of Sponsor	2	2
Overall Study Protocol Violation	0	1
Overall Study Physician Decision	1	0

Baseline Characteristics

A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=94 Participants Placebo tablet, once daily by mouth, 6 weeks	Pimavanserin 40 mg n=104 Participants Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks	Total n=198 Participants Total of all reporting groups
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	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	83 Participants n=5 Participants	92 Participants n=7 Participants	175 Participants n=5 Participants
Age, Continuous	72.7 years STANDARD_DEVIATION 8.03 • n=5 Participants	72.6 years STANDARD_DEVIATION 6.49 • n=7 Participants	72.7 years STANDARD_DEVIATION 7.25 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	70 Participants n=7 Participants	126 Participants n=5 Participants
Region of Enrollment United States	92 participants n=5 Participants	101 participants n=7 Participants	193 participants n=5 Participants
Region of Enrollment Canada	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Each study visit (i.e. Days 1, 15, 29 and 43)

Population: This is the "Intent to Treat" population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date.

Outcome measures

Outcome measures
Measure	Placebo n=90 Participants Placebo tablet, once daily by mouth, 6 weeks	Pimavanserin 40 mg n=95 Participants Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Antipsychotic Efficacy Change from Baseline	-2.73 Score on the SAPS-PD scale Interval -4.05 to -1.42	-5.79 Score on the SAPS-PD scale Interval -7.09 to -4.49
Antipsychotic Efficacy Difference of Least Squares Mean versus Placebo	NA Score on the SAPS-PD scale Calculation is a comparison of active arm versus placebo.	-3.06 Score on the SAPS-PD scale Interval -4.91 to -1.2

SECONDARY outcome

Timeframe: Study Days 1 and 43

Motor symptoms were measured using the change from baseline to Day 43 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The possible total score is 0 to 160 and a negative change in score indicates improvement. Analysis Method: Analysis of Covariance (ANCOVA). The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between the pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5.

Outcome measures

Outcome measures
Measure	Placebo n=90 Participants Placebo tablet, once daily by mouth, 6 weeks	Pimavanserin 40 mg n=95 Participants Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Motor Symptoms Change From Baseline (Negative = Improvement) Change from Baseline	-1.69 Score on the UPDRS-II+III Interval -3.43 to 0.05	-1.40 Score on the UPDRS-II+III Interval -3.1 to 0.3
Motor Symptoms Change From Baseline (Negative = Improvement) Difference of Least Squares Mean versus Placebo	NA Score on the UPDRS-II+III Calculation is a comparison of active arm versus placebo.	0.29 Score on the UPDRS-II+III Interval -2.14 to 2.72

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

Pimavanserin 40 mg

Serious events: 11 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=94 participants at risk Placebo tablet, once daily by mouth, 6 weeks	Pimavanserin 40 mg n=104 participants at risk Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Gastrointestinal disorders Nausea	6.4% 6/94 • Number of events 6 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	5.8% 6/104 • Number of events 7 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
General disorders Edema peripheral	3.2% 3/94 • Number of events 3 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	6.7% 7/104 • Number of events 7 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Infections and infestations Urinary tract infection	11.7% 11/94 • Number of events 12 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	13.5% 14/104 • Number of events 16 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Injury, poisoning and procedural complications Fall	8.5% 8/94 • Number of events 9 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	10.6% 11/104 • Number of events 14 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Nervous system disorders Confusional state	3.2% 3/94 • Number of events 4 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	5.8% 6/104 • Number of events 6 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Nervous system disorders Headache	5.3% 5/94 • Number of events 5 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Psychiatric disorders Hallucination	1.1% 1/94 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	6.7% 7/104 • Number of events 9 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.

Additional Information

Roger Mills, MD

ACADIA Pharmaceuticals Inc.

Phone: 858-202-7563

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator may publish the study results, relative to his/her own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the sponsor for review and comment. The sponsor has 60 days to review and comment.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=94 participants at risk Placebo tablet, once daily by mouth, 6 weeks	Pimavanserin 40 mg n=104 participants at risk Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Cardiac disorders Arrhythmia	1.1% 1/94 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.00% 0/104 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Cardiac disorders Atrial fibrillation	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Cardiac disorders Cardio-respiratory arrest	1.1% 1/94 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.00% 0/104 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Gastrointestinal disorders Hemorrhoids	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
General disorders Asthenia	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
General disorders Fatigue	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
General disorders Multi-organ failure	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Infections and infestations Urinary tract infection	1.1% 1/94 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	2.9% 3/104 • Number of events 3 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Infections and infestations Bronchitis	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Infections and infestations Sepsis	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Infections and infestations Septic shock	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Injury, poisoning and procedural complications Fall	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Injury, poisoning and procedural complications Fracture	1.1% 1/94 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.00% 0/104 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Metabolism and nutrition disorders Dehydration	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Nervous system disorders Parkinson's disease	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Nervous system disorders Transient ischemic attack	1.1% 1/94 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.00% 0/104 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Psychiatric disorders Psychotic disorder	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	1.9% 2/104 • Number of events 2 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Psychiatric disorders Hallucination	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Psychiatric disorders Mental status changes	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Psychiatric disorders Sleep disorder	0.00% 0/94 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.96% 1/104 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
Skin and subcutaneous tissue disorders Decubitus ulcer	1.1% 1/94 • Number of events 1 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.	0.00% 0/104 • 6 weeks From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.