Efficacy and Safety of ACT-541468 in Adult Subjects With... | NCT02839200 | Trialant
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Studies Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder NCT02839200 Show options Idorsia Pharmaceuticals Ltd.
ACT-541468 5 mg ACT-541468 10 mg ACT-541468 25 mg Zolpidem Placebo 1 Placebo 2 United States Germany Hungary Israel Spain Sweden Obsolete or Duplicate NCT IDs Not provided
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Multi-center, Double-blind, Randomized, Placebo-controlled, Active-reference, Parallel-group, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Idorsia Pharmaceuticals Ltd. INDUSTRY
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Jul 18, 2016
Results First Submitted Date Mar 6, 2020
Results First Submitted that Met QC Criteria Mar 20, 2020
Results First Posted Date Apr 2, 2020 Actual
Certification/Extension (aka Delayed Results) First Submitted Date Apr 26, 2018
Certification/Extension First Submitted that Passed QC Review Apr 26, 2018
Certification/Extension First Posted Date Apr 27, 2018 Actual
Last Update Submitted Date Apr 1, 2020
Responsible Party, by Official Title Sponsor
Idorsia Pharmaceuticals Ltd. INDUSTRY
Has Data Monitoring Committee (DMC) Yes
Pediatric Postmarket Surveillance of a Device Product Not provided
This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.
This study consists of the following phases: screening phase; double-blind treatment phase; safety follow-up phase. Safety is monitored throughout the study.
Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names ACT-541468 5 mg Experimental Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
Drug: ACT-541468 5 mg Drug: Placebo 1 ACT-541468 10 mg Experimental Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
Drug: ACT-541468 10 mg Drug: Placebo 1 ACT-541468 25 mg Experimental Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
Drug: ACT-541468 25 mg Drug: Placebo 1 ACT-541468 50 mg Experimental Each subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
Zolpidem Active Comparator Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Drug: Zolpidem Drug: Placebo 2
Name Type Description Arm Group Labels Other Names ACT-541468 5 mg Drug Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Measure Description Time Frame Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)
Baseline and Days 1&2
Measure Description Time Frame Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2 LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG
Baseline and Days 1&2 Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4
Principal inclusion Criteria:
Signed informed consent prior to any study-mandated procedure.
Male or female aged 18-64 years (inclusive).
Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT.
Body mass index (BMI): 18.5 ≤ BMI (kg/m2) < 32.0.
Insomnia disorder according to DSM-5 criteria.
Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
Insomnia Severity Index score ≥ 15.
Principal exclusion Criteria:
Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
Caffeine consumption ≥ 600 mg per day.
Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel > or= 3 time zones during study.
Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
AST and/or ALT > 2 × ULN and/or direct bilirubin > 1.5 × ULN (except known history of Gilbert's syndrome).
Severe renal impairment (known or defined as estimated creatinine clearance < 30 mL/min).
History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Accepts Healthy Volunteers No
Name Affiliation Role Clinical Trials Idorsia Pharmaceuticals Ltd. Study Director
Facility Status City State ZIP Country Contacts Investigator Site Santa Monica California 90404 United States Investigator Site
PubMed Identifier Type Citation Retractions Derived Dutta S, Singhal S, Shah R, Charan J, Dhingra S, Haque M. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1237-1251. doi: 10.1080/14740338.2023.2243217. Epub 2023 Aug 7. Derived Di Marco T, Scammell TE, Meinel M, Seboek Kinter D, Datta AN, Zammit G, Dauvilliers Y. Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem. CNS Drugs. 2023 Jul;37(7):639-653. doi: 10.1007/s40263-023-01020-9. Epub 2023 Jul 21.
Available IPD Information Not provided
No data available
No data is available for this block.
Screening details: screening period (screening visit followed by at least 7 days at home) and a run-in period (2 PSG nights on single-blind placebo, followed by 5-12 days with no treatment), and lasting a max. of 28 days. N = 360 subjects were randomized; N = 359 subjects were treated; N = 1 subject discontinued due to "randomization error".
Conducted at 38 sites in 6 countries (Germany, Hungary, Israel, Spain, Sweden, and the USA)
ID Title Description FG000 ACT-541468 5 mg Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
FG001
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED
Baseline Analysis Population Description Not provided
No data available
No data is available for this block.
Document Has No Statistical Analysis Plan (SAP) Not provided
Uploaded Document Information Type Includes Protocol Includes SAP Includes ICF Document Label Document Date Document Uploaded Date Document File Name Prot Yes No No Study Protocol Dec 16, 2016 Feb 26, 2020
No data available
No data is available for this block.
Randomized
Intervention Model Description Not provided
Participant Care Provider Investigator Outcomes Assessor
Placebo Placebo Comparator Each subject receives two placebo capsules, once daily in the evening for 4 weeks
ACT-541468 10 mg Drug Capsule for oral administration containing ACT-541468 at a strength of 10 mg
ACT-541468 25 mg Drug Capsule for oral administration containing ACT-541468 at a strength of 25 mg
ACT-541468 25 mg ACT-541468 50 mg
Zolpidem Drug Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 1 Drug Placebo capsules matching ACT-541468 capsules
ACT-541468 10 mg ACT-541468 25 mg ACT-541468 5 mg Placebo
Placebo 2 Drug Placebo capsules matching over-encapsulated zolpidem
sLSO is the self-reported time to fall asleep, as reported in the sleep diary
Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4 sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.
Baseline and Week 4
Investigator Site Brandon Florida 33511 United States
Investigator Site Clearwater Florida 33765 United States
Investigator Site Coral Gables Florida 33134 United States
Investigator Site DeLand Florida 32720 United States
Investigator Site Hollywood Florida 33024 United States
Investigator Site Miami Florida 33143 United States
Investigator Site Atlanta Georgia 30342 United States
Investigator Site Chicago Illinois 60634 United States
Investigator Site Indianapolis Indiana 46250 United States
Investigator Site Novi Michigan 48377 United States
Investigator Site Las Vegas Nevada 89104 United States
Investigator Site New York New York 10019 United States
Investigator Site Cincinnati Ohio 45255 United States
Investigator Site Berlin 10115 Germany
Investigator Site Berlin 10117 Germany
Investigator Site Berlin 12203 Germany
Investigator Site Dresden 01069 Germany
Investigator Site Hamburg 20251 Germany
Investigator Site Hamburg 20253 Germany
Investigator Site Hanover 30159 Germany
Investigator Site Schwerin 19053 Germany
Investigator Site Schwerin 19055 Germany
Investigator Site Budapest 1134 Hungary
Investigator Site Szeged 6725 Hungary
Investigator Site Törökbálint 2045 Hungary
Investigator Site Beersheba 84101 Israel
Investigator Site Haifa 31096 Israel
Investigator Site Barcelona 08017 Spain
Investigator Site Barcelona 08035 Spain
Investigator Site Madrid 28036 Spain
Investigator Site Zaragoza 50015 Spain
Investigator Site Gothenburg 413 90 Sweden
Investigator Site Örebro 701 85 Sweden
Derived Dauvilliers Y, Zammit G, Fietze I, Mayleben D, Seboek Kinter D, Pain S, Hedner J. Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder. Ann Neurol. 2020 Mar;87(3):347-356. doi: 10.1002/ana.25680. Epub 2020 Feb 5.
Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
FG002 ACT-541468 25 mg Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
FG003 ACT-541468 50 mg Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
FG004 Zolpidem Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
FG005 Placebo Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
FG000 60 subjects
FG001 59 subjects
FG002 60 subjects
FG003 61 subjects
FG004 60 subjects
FG005 60 subjects COMPLETED FG000 56 subjects FG001 58 subjects FG002 59 subjects FG003 61 subjects FG004 58 subjects FG005 59 subjects
NOT COMPLETED FG000 4 subjects FG001 1 subjects FG002 1 subjects FG003 0 subjects FG004 2 subjects FG005 1 subjects
Type Comment Reasons Withdrawal by Subject FG000 2 subjects FG001 0 subjects FG002 1 subjects FG003 0 subjects FG004 0 subjects FG005 1 subjects Lost to Follow-up FG000 2 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004 Adverse Event FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004 Randomized in error FG000 0 subjects FG001 1 subjects FG002 0 subjects FG003 0 subjects FG004
Type of Units Analyzed
ID Title Description BG000 ACT-541468 5 mg Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
BG001 ACT-541468 10 mg Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
BG002 ACT-541468 25 mg Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
BG003 ACT-541468 50 mg Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
BG004 Zolpidem Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
BG005 Placebo Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
BG006 Total Total of all reporting groups
Units Counts Participants BG000 60 BG001 58 BG002 60 BG003 61 BG004 60 BG005 60 BG006 359
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Continuous Median Full Range years Title Denominators Categories Title Measurements BG000 41 (22 to 64) BG001 48 (21 to 63) BG002 48 (18 to 64) BG003
Age, Customized Age categorical (Unit: subjects)
Count of Participants Participants Title Denominators Categories Adults (18-64 years)
Sex: Female, Male Count of Participants Participants Title Denominators Categories
Ethnicity (NIH/OMB) Count of Participants Participants Title Denominators Categories Title Measurements Hispanic or Latino
Race (NIH/OMB) Count of Participants Participants Title Denominators Categories Title Measurements American Indian or Alaska Native
Type Title Description Population Description Reporting Status Anticipated Posting Date Parameter Type Dispersion Type Unit of Measure Calculate Percentage Time Frame Units Analyzed Denominator Units Selected Arm/Group Information Denominators Classes Analyses Primary Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)
Posted Least Squares Mean Standard Error minutes Baseline and Days 1&2 ID Title Description OG000 ACT-541468 5 mg Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG001 ACT-541468 10 mg Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG002 ACT-541468 25 mg Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG003 ACT-541468 50 mg Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
OG004 Zolpidem Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
OG005 Placebo Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
Units Counts Participants OG000 60 OG001 58 OG002 60 OG003
Title Denominators Categories Title Measurements OG000 -28.4 ± 4.24 OG001 -32.3 ± 4.32 OG002 -37.7 ± 4.25 OG003
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description OG000 OG001 OG002 OG003 OG005 Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all ACT-541468 doses. The null hypothesis of "no dose-response" was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value <0.05. The analysis was performed using the R-package "DoseFinding" (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)
Multiple Comparison Procedure-Model <0.001 Other
Secondary Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2 LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG
Posted Mean Standard Deviation Minutes Baseline and Days 1&2 ID Title Description OG000 ACT-541468 5 mg Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG001 ACT-541468 10 mg Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG002 ACT-541468 25 mg Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG003
Secondary Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4 sLSO is the self-reported time to fall asleep, as reported in the sleep diary
Posted Mean Standard Deviation Minutes Baseline and Week 4 ID Title Description OG000 ACT-541468 5 mg Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG001 ACT-541468 10 mg Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG002 ACT-541468 25 mg Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG003
Secondary Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4 sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.
Posted Mean Standard Deviation Minutes Baseline and Week 4 ID Title Description OG000 ACT-541468 5 mg Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG001 ACT-541468 10 mg Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG002 ACT-541468 25 mg Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
OG003
Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 ACT-541468 5 mg Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
0 60 0 60 21 60 EG001 ACT-541468 10 mg Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
0 58 2 58 22 58 EG002 ACT-541468 25 mg Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
0 60 0 60 23 60 EG003 ACT-541468 50 mg Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
0 61 1 61 21 61 EG004 Zolpidem Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
0 60 0 60 24 60 EG005 Placebo Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
0 60 0 60 18 60
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Myocardial infarction Cardiac disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 0 events 0 affected 61 at risk EG004 0 events 0 affected 60 at risk EG005 0 events 0 affected 60 at risk Accident at work Injury, poisoning and procedural complications MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Craniocerebral injury Injury, poisoning and procedural complications MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Angioedema Skin and subcutaneous tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Eosinophilia Blood and lymphatic system disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 0 events 0 affected 61 at risk EG004 0 events 0 affected 60 at risk EG005 0 events 0 affected 60 at risk Neutropenia Blood and lymphatic system disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Arrhythmia Cardiac disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Atrial tachycardia Cardiac disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Atrioventricular block first degree Cardiac disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Defect conduction intraventricular Cardiac disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Palpitations Cardiac disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Sinus bradycardia Cardiac disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Ventricular extrasystoles Cardiac disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Ear pain Ear and labyrinth disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Paraesthesia ear Ear and labyrinth disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Vertigo Ear and labyrinth disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Chromatopsia Eye disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Vision blurred Eye disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Abdominal discomfort Gastrointestinal disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Abdominal distension Gastrointestinal disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Abdominal pain upper Gastrointestinal disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Constipation Gastrointestinal disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Diarrhoea Gastrointestinal disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 3 events 3 affected 60 at risk EG003 Dry mouth Gastrointestinal disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Dyspepsia Gastrointestinal disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Faeces pale Gastrointestinal disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Flatulence Gastrointestinal disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Nausea Gastrointestinal disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 2 events 2 affected 60 at risk EG003 Chest discomfort General disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Fatigue General disorders MedDRA (19.0) Non-systematic Assessment EG000 2 events 1 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 3 events 3 affected 60 at risk EG003 Feeling hot General disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Gait disturbance General disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Influenza like illness General disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Medical device site erythema General disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Medical device site inflammation General disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Medical device site irritation General disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Medical device site pain General disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Pyrexia General disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Cholelithiasis Hepatobiliary disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Seasonal allergy Immune system disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Acute sinusitis Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Gastroenteritis Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Gastroenteritis viral Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Helicobacter infection Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Influenza Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Nasopharyngitis Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 2 events 2 affected 60 at risk EG001 2 events 2 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Pharyngitis Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Rash pustular Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Tonsillitis Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Tooth infection Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Upper respiratory tract infection Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Vulvovaginal mycotic infection Infections and infestations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Fall Injury, poisoning and procedural complications MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Hand fracture Injury, poisoning and procedural complications MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Joint injury Injury, poisoning and procedural complications MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Ligament sprain Injury, poisoning and procedural complications MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Limb injury Injury, poisoning and procedural complications MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Alanine aminotransferase increased Investigations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 2 events 2 affected 60 at risk EG003 Aspartate aminotransferase increased Investigations MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Bilirubin conjugated increased Investigations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Blood bilirubin increased Investigations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Blood calcium decreased Investigations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Blood cholesterol increased Investigations MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Blood creatine phosphokinase increased Investigations MedDRA (19.0) Non-systematic Assessment EG000 2 events 2 affected 60 at risk EG001 2 events 1 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 ECG signs of myocardial infarction Investigations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Electrocardiogram QT prolonged Investigations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Electrocardiogram T wave inversion Investigations MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Gamma-glutamyltransferase increased Investigations MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 2 events 2 affected 60 at risk EG003 Weight increased Investigations MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 White blood cell count decreased Investigations MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Hyperkalaemia Metabolism and nutrition disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Hypocalcaemia Metabolism and nutrition disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Increased appetite Metabolism and nutrition disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Arthralgia Musculoskeletal and connective tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Back pain Musculoskeletal and connective tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Muscle tightness Musculoskeletal and connective tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Myalgia Musculoskeletal and connective tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 2 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Neck pain Musculoskeletal and connective tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Pain in extremity Musculoskeletal and connective tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Balance disorder Nervous system disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Cervicobrachial syndrome Nervous system disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Dizziness Nervous system disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 4 events 2 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Dizziness postural Nervous system disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Dysarthria Nervous system disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Dysgeusia Nervous system disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Headache Nervous system disorders MedDRA (19.0) Non-systematic Assessment EG000 7 events 6 affected 60 at risk EG001 5 events 5 affected 58 at risk EG002 5 events 5 affected 60 at risk EG003 Hypersomnia Nervous system disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Somnolence Nervous system disorders MedDRA (19.0) Non-systematic Assessment EG000 4 events 3 affected 60 at risk EG001 3 events 3 affected 58 at risk EG002 5 events 4 affected 60 at risk EG003 Abnormal dreams Psychiatric disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Anxiety Psychiatric disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Insomnia Psychiatric disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Nervousness Psychiatric disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Nightmare Psychiatric disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Stress Psychiatric disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Bladder discomfort Renal and urinary disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Nephrolithiasis Renal and urinary disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Nocturia Renal and urinary disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Renal pain Renal and urinary disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Dysmenorrhoea Reproductive system and breast disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Cough Respiratory, thoracic and mediastinal disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 2 events 1 affected 60 at risk EG003 Epistaxis Respiratory, thoracic and mediastinal disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Nasal congestion Respiratory, thoracic and mediastinal disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Oropharyngeal pain Respiratory, thoracic and mediastinal disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 1 events 1 affected 60 at risk EG003 Pharyngeal erythema Respiratory, thoracic and mediastinal disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Productive cough Respiratory, thoracic and mediastinal disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Acne Skin and subcutaneous tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Dermatitis contact Skin and subcutaneous tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Erythema Skin and subcutaneous tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 2 events 2 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Photosensitivity reaction Skin and subcutaneous tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 1 events 1 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Pruritus Skin and subcutaneous tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Pruritus generalised Skin and subcutaneous tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Urticaria Skin and subcutaneous tissue disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Coronary arterial stent insertion Surgical and medical procedures MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 1 events 1 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003 Hot flush Vascular disorders MedDRA (19.0) Non-systematic Assessment EG000 0 events 0 affected 60 at risk EG001 0 events 0 affected 58 at risk EG002 0 events 0 affected 60 at risk EG003
Are all PI(s) employees of the sponsor? No
Results Disclosure Restriction on PI(s)? No
Title Organization Phone Extension Email Clinical Trial Disclosure Desk Idorsia Pharmaceuticals +41 588 441977 clinical-trials-disclosure@idorsia.com
SAP No Yes No Statistical Analysis Plan Jul 3, 2017 Feb 26, 2020
ID Term D007319 Sleep Initiation and Maintenance Disorders
ID Term D020919 Sleep Disorders, Intrinsic D020920 Dyssomnias D012893 Sleep Wake Disorders D009422 Nervous System Diseases D001523 Mental Disorders
ID Term C000634383 daridorexant D000077334 Zolpidem
ID Term D011725 Pyridines D006573 Heterocyclic Compounds, 1-Ring D006571 Heterocyclic Compounds
1 subjects
FG005 0 subjects 1 subjects
FG005 0 subjects 0 subjects
FG005 0 subjects 46
(18 to 63)
BG004 43 (23 to 61)
BG005 48 (23 to 64)
BG006 47 (18 to 64) 60
BG003 61
BG004 60
BG005 60
BG006 359 39
BG003 39
BG004 38
BG005 38
BG006 230 Male BG000 22 BG001 20 BG002 21 BG003 22 BG004 22 BG005 22 BG006 129
9
BG003 5
BG004 4
BG005 9
BG006 39 Not Hispanic or Latino BG000 51 BG001 54 BG002 51 BG003 56 BG004 56 BG005 51 BG006 319
Unknown or Not Reported BG000 0 BG001 1 BG002 0 BG003 0 BG004 0 BG005 0 BG006 1
0
BG003 0
BG004 0
BG005 0
BG006 0 Asian BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 1 BG006 1
Native Hawaiian or Other Pacific Islander BG000 0 BG001 1 BG002 0 BG003 0 BG004 0 BG005 0 BG006 1
Black or African American BG000 5 BG001 8 BG002 4 BG003 5 BG004 6 BG005 7 BG006 35
White BG000 54 BG001 49 BG002 56 BG003 56 BG004 54 BG005 52 BG006 321
More than one race BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0
Unknown or Not Reported BG000 1 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 1
61
OG004 60
OG005 60 -47.1
± 4.21
OG004 -29.9 ± 4.30
OG005 -21.4 ± 4.24 ANCOVA 0.241 LS mean difference -7 Standard Error of the Mean 5.95 2-Sided 95 -18.7 4.7 Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean
Other
ANCOVA 0.072 LS Mean difference -10.8 Standard Error of the Mean 6 2-Sided 95 -22.6 1 Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean
Other
ANCOVA 0.007 LS Mean difference -16.2 Standard Error of the Mean 5.95 2-Sided 95 -27.9 -4.5 Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean
Other
ANCOVA < 0.001 LS Mean difference -25.6 Standard Error of the Mean 5.92 2-Sided 95 -37.3 -13.9 Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean
Other
ANCOVA 0.155 LS Mean difference -8.5 Standard Error of the Mean 5.97 2-Sided 95 -20.4 3.3 Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean
Other
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
OG004 Zolpidem Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
OG005 Placebo Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
Units Counts Participants OG000 60 OG001 58 OG002 60 OG003 61 OG004 60 OG005 60
Title Denominators Categories Title Measurements OG000 -26.88 ± 45.42 OG001 -29.31 ± 26.79 OG002 -36.14 ± 34.34 OG003 -36.41 ± 26.71 OG004 -45.14 ± 32.82 OG005 -22.02 ± 46.63
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
OG004 Zolpidem Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
OG005 Placebo Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
Units Counts Participants OG000 60 OG001 58 OG002 60 OG003 61 OG004 60 OG005 60
Title Denominators Categories Title Measurements OG000 -13.38 ± 27.79 OG001 -21.07 ± 24.26 OG002 -15.50 ± 25.51 OG003 -23.65 ± 24.12 OG004 -19.98 ± 19.28 OG005 -16.32 ± 21.16
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
OG004 Zolpidem Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
OG005 Placebo Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
Units Counts Participants OG000 51 OG001 45 OG002 53 OG003 49 OG004 48 OG005 50
Title Denominators Categories Title Measurements OG000 -31.32 ± 33.32 OG001 -24.35 ± 33.4 OG002 -29.8 ± 39.88 OG003 -35.45 ± 37.53 OG004 -29.08 ± 27.28 OG005 -23.61 ± 32.62
0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 1 events 1 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 1 events 1 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 1 events 1 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 1 events 1 affected 60 at risk 1 events
1 affected
61 at risk
EG004 5 events 4 affected 60 at risk
EG005 3 events 1 affected 60 at risk 1 events
1 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 2 events 2 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 5 events 4 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 5 events 4 affected 60 at risk
EG005 2 events 2 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 2 events 1 affected 60 at risk 0 events
0 affected
61 at risk
EG004 2 events 2 affected 60 at risk
EG005 1 events 1 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 1 events 1 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 1 events 1 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 2 events
2 affected
61 at risk
EG004 5 events 5 affected 60 at risk
EG005 4 events 4 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 1 events 1 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 1 events 1 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 2 events 2 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 1 events 1 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 4 events 4 affected 60 at risk
EG005 1 events 1 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 6 events
5 affected
61 at risk
EG004 8 events 6 affected 60 at risk
EG005 1 events 1 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 5 events
4 affected
61 at risk
EG004 3 events 3 affected 60 at risk
EG005 3 events 3 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
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1 affected
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EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 1 events 1 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 1 events 1 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
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2 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 1 events
1 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
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EG004 0 events 0 affected 60 at risk
EG005 0 events 0 affected 60 at risk 0 events
0 affected
61 at risk
EG004 0 events 0 affected 60 at risk
EG005 1 events 1 affected 60 at risk