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| ID | Type | Description | Link |
|---|---|---|---|
| 54135419TRD3008 | Other Identifier | Janssen Research & Development, LLC | |
| 2015-003578-34 | EudraCT Number |
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The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).
This is an open-label (the researchers and participants know the treatment the participant is receiving) long-term extension study. The study will consist of 2 open-label Phases: 4-week Induction phase (if applicable) and Open-Label Optimization/Maintenance phase (variable). Participants will enter the study Induction Phase from ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3005 (NCT02422186) and ESKETINTRD3006 (US sites only). Participants will enter the study Open-Label Optimization/Maintenance phase from ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868) (if appropriate at week 16) or ESKETINTRD3006 (US sites only). In the Open-Label Induction Phase, participants will self-administer flexibly-dosed esketamine nasal spray. During first 4 weeks in Optimization/Maintenance Phase responder participants from the induction phase of study 54135419TRD3008, will continue on the same dose of esketamine nasal spray from the induction phase and have a weekly intranasal treatment session frequency. Participants entering the optimization/maintenance phase from study ESKETINTRD3005 will also have a weekly intranasal treatment session frequency. However, as the ESKETINTRD3005 intranasal study medication is blinded at the time of entry into the current study, the dose of esketamine nasal spray will be administered as outlined in protocol. Participants entering the optimization/maintenance phase from study ESKETINTRD3003 (Direct Entry) or ESKETINTRD3004 who were ongoing in the Optimization, Maintenance, or Optimization/Maintenance phase, respectively, will have the option to have their current intranasal dosing frequency adjusted at the time of entry into 54135419TRD3008 study and should remain on the selected frequency from week 1 to week 4. A one-time dose change will be permitted at study entry. After 4 weeks, esketamine nasal spray treatment sessions will be individualized to either once weekly or once every other week at the fixed 2-week interval (based on clinical global impression - severity [CGI-S] performed at that visit), and every 4 weeks for participants dosed at the 4 week interval. Participants safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esketamine Nasal Spray | Experimental | Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram [mg] or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3004 (NCT02497287), or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine Nasal Spray | Drug | Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram [mg] or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585) or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score | This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. The DET is a measure of psychomotor function and uses a well-validated simple reaction time. In this outcome measure, speed of performance of subjects (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranged from 2 to 3.3 log 10 milliseconds (msec). Lower score indicated better performance. Higher change from baseline indicated better performance. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score | This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. IDN test is a measure of visual attention (choice reaction time) and scored for speed of response (mean of the log10 transformed reaction times for correct responses). Total score ranged from 2 to 3.3 log 10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score | This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. OCL test is a measure of visual episodic memory and visual recall test scored using arcsine transformation of the percentage of correct responses (CR). The range for OCL is 0 to 100 percent (%) accuracy; presented as an arcsin transformation, the range is 0 to 1.57. Higher score indicated better performance. Higher change from baseline indicated better performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score | MADRS measures depression severity, detects changes due to AD treatment. It consists of 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe conditions. Negative change in score indicates improvement. Missing data was imputed using last observation carried forward (LOCF) method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40319349 | Derived | Zaki N, Chen LN, Lane R, Doherty T, Drevets WC, Morrison RL, Sanacora G, Wilkinson ST, Young AH, Lacerda ALT, Paik JW, Popova V, Fu DJ. Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study. Int J Neuropsychopharmacol. 2025 Jun 6;28(6):pyaf027. doi: 10.1093/ijnp/pyaf027. | |
| 37558912 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Esketamine Nasal Spray | Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams [mg] or 84 mg for participants less than [<] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to [>=] 65 years). Participants who entered the optimization and maintenance phase (OP/MA) from the IND phase of study NCT02782104 continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or ESKETINTRD3006 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered from study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in OP/MP. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 5, 2020 | Dec 29, 2023 |
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| IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score | The ONB is a measure of working memory and scored for speed of correct response (mean of the log10-transformed reaction times for correct responses). Total score ranged from 2 to 3.54 log10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score | This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. GMLT measures executive function; maze/sequencing test, scored for total number of errors. Total score ranged from 0 to 999 number of errors. Lower score indicated better performance. Higher change from baseline indicated better performance. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Study Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score | The HVLT-R measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0-12); the total number of true-positive errors (0-12); and the range of recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher total recall score indicated higher cognition. The range of the recognition discrimination index is -12 to 12. Higher score indicated better performance and higher change from baseline indicated better performance. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Percentage of Participants Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score | C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and behavior, to assess whether participant experienced any of following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Here, percentage of participants with >=1 positive behavior, participants with >=1 positive ideations; no event were reported. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent. | IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months |
| Change From Baseline in Heart Rate | Change from baseline (predose) in heart rate were reported. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Baseline in Systolic and Diastolic Blood Pressure | Change from baseline in systolic and diastolic blood pressure were reported. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Baseline in Respiratory Rate | Change from baseline in respiratory rate were reported. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Baseline in Blood Oxygen Saturation | Change from baseline in blood oxygen saturation (predose) were reported. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score | Change from baseline in PHQ-9 total score were reported. The PHQ-9 was a 9-item, patient-reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders. Each item was rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses were summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Baseline in Clinical Global Impression-severity (CGI-S) Score | Change from baseline in clinical global impression-severity (CGI-S) score were reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative change in score indicates improvement. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score | Change from baseline in SDS total score were reported. The SDS, a patient-reported outcome measure, was a 5 item questionnaire which had been widely used and accepted for assessment of functional and associated disability impairment. The first three items assessed disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items were summed to create a total score of 0-30 where a higher score indicated greater impairment. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Baseline in Participant-Reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Valuation Index Score (VAS) | Change from baseline in participant-reported health-related quality of life as assessed by EQ-5D-5L VAS was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Baseline as Assessed by EQ 5D-5L: Sum Score | EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Change From Baseline in Participant- Reported Health Related Quality of Life Using the Quality of Life in Depression Scale (QLDS) | Change from baseline in participant- reported health related quality of life using the QLDS. The QLDS is a disease-specific validated patient-reported outcome (PRO) measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of "1" or "0". A score of "1" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition. | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
| Little Rock |
| Arkansas |
| United States |
| Garden Grove | California | United States |
| Glendale | California | United States |
| Oakland | California | United States |
| Orange | California | United States |
| San Diego | California | United States |
| San Rafael | California | United States |
| Hartford | Connecticut | United States |
| New Haven | Connecticut | United States |
| Gainesville | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Hoffman Estates | Illinois | United States |
| Joliet | Illinois | United States |
| Maywood | Illinois | United States |
| Skokie | Illinois | United States |
| Iowa City | Iowa | United States |
| Wichita | Kansas | United States |
| Lake Charles | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Baltimore | Maryland | United States |
| Gaithersburg | Maryland | United States |
| Boston | Massachusetts | United States |
| New Bedford | Massachusetts | United States |
| Watertown | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Rochester Hills | Michigan | United States |
| O'Fallon | Missouri | United States |
| Saint Charles | Missouri | United States |
| Omaha | Nebraska | United States |
| Cedarhurst | New York | United States |
| New York | New York | United States |
| Staten Island | New York | United States |
| Hickory | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Allentown | Pennsylvania | United States |
| Media | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Lincoln | Rhode Island | United States |
| Providence | Rhode Island | United States |
| Charleston | South Carolina | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Wichita Falls | Texas | United States |
| Charlottesville | Virginia | United States |
| Waukesha | Wisconsin | United States |
| Banfield | Argentina |
| Buenos Aires | Argentina |
| Córdoba | Argentina |
| La Plata | Argentina |
| Mendoza | Argentina |
| Rosario | Argentina |
| Caulfield | Australia |
| Elizabeth Vale | Australia |
| Frankston | Australia |
| Vienna | Austria |
| Aalst | Belgium |
| Bruges | Belgium |
| Brussels | Belgium |
| Heusden-Zolder | Belgium |
| Liège | Belgium |
| Yvoir | Belgium |
| Belo Horizonte | Brazil |
| Curitiba | Brazil |
| Fortaleza | Brazil |
| Passo Fundo | Brazil |
| Porto Alegre | Brazil |
| Recife | Brazil |
| Rio de Janeiro | Brazil |
| São Bernardo do Campo | Brazil |
| São Paulo | Brazil |
| Burgas | Bulgaria |
| Kardzhali | Bulgaria |
| Pazardzhik | Bulgaria |
| Pleven | Bulgaria |
| Plovdiv | Bulgaria |
| Rousse | Bulgaria |
| Sofia | Bulgaria |
| Varna | Bulgaria |
| Vancouver | British Columbia | Canada |
| Kingston | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Brno | Czechia |
| Pilsen | Czechia |
| Prague | Czechia |
| Tallinn | Estonia |
| Tartu | Estonia |
| Kuopio | Finland |
| Clermont-Ferrand | France |
| Douai | France |
| Nantes | France |
| Nîmes | France |
| Paris | France |
| Poitiers | France |
| Toulon | France |
| Berlin | Germany |
| Bochum | Germany |
| Mainz | Germany |
| Mittweida | Germany |
| Oranienburg | Germany |
| Pfaffenhofen | Germany |
| Budapest | Hungary |
| Debrecen | Hungary |
| Győr | Hungary |
| Pécs | Hungary |
| Sopron | Hungary |
| Szekszárd | Hungary |
| Vác | Hungary |
| Kaunas | Lithuania |
| Kuala Lumpur | Malaysia |
| Guadalajara | Mexico |
| León | Mexico |
| Mexico City | Mexico |
| México | Mexico |
| Monterrey | Mexico |
| San Luis Potosí City | Mexico |
| Bełchatów | Poland |
| Bialystok | Poland |
| Bydgoszcz | Poland |
| Gdansk | Poland |
| Leszno | Poland |
| Lublin | Poland |
| Warsaw | Poland |
| Bratislava | Slovakia |
| Liptovský Mikuláš | Slovakia |
| Rimavská Sobota | Slovakia |
| Rožňava | Slovakia |
| Svidník | Slovakia |
| Cape Town | South Africa |
| Pretoria | South Africa |
| Welgemoed | South Africa |
| Gwangju | South Korea |
| Seoul | South Korea |
| Alcorcón | Spain |
| Barcelona | Spain |
| Bilbao | Spain |
| Madrid | Spain |
| Oviedo | Spain |
| Palma | Spain |
| Pamplona | Spain |
| Sabadell | Spain |
| Salamanca | Spain |
| Sant Boi de Llobregat | Spain |
| Torrevieja | Spain |
| Vitoria-Gasteiz | Spain |
| Zamora | Spain |
| Halmstad | Sweden |
| Lund | Sweden |
| Skövde | Sweden |
| Stockholm | Sweden |
| Kaohsiung City | Taiwan |
| New Taipei City | Taiwan |
| Taichung | Taiwan |
| Taipei | Taiwan |
| Taoyuan | Taiwan |
| Adana | Turkey (Türkiye) |
| Ankara | Turkey (Türkiye) |
| Bursa | Turkey (Türkiye) |
| Istanbul | Turkey (Türkiye) |
| Kucukcekmece/Istanbul | Turkey (Türkiye) |
| Oanakkale | Turkey (Türkiye) |
| Samsun | Turkey (Türkiye) |
| Chesterfield | United Kingdom |
| Derby | United Kingdom |
| London | United Kingdom |
| Northampton | United Kingdom |
| Oxford | United Kingdom |
| Castro M, Wilkinson ST, Al Jurdi RK, Petrillo MP, Zaki N, Borentain S, Fu DJ, Turkoz I, Sun L, Brown B, Cabrera P. Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study. CNS Drugs. 2023 Aug;37(8):715-723. doi: 10.1007/s40263-023-01026-3. Epub 2023 Aug 9. |
| 37173512 | Derived | Zaki N, Chen LN, Lane R, Doherty T, Drevets WC, Morrison RL, Sanacora G, Wilkinson ST, Popova V, Fu DJ. Long-term safety and maintenance of response with esketamine nasal spray in participants with treatment-resistant depression: interim results of the SUSTAIN-3 study. Neuropsychopharmacology. 2023 Jul;48(8):1225-1233. doi: 10.1038/s41386-023-01577-5. Epub 2023 May 12. |
| 32818917 | Derived | Starr HL, Abell J, Larish A, Lewis S, DeMuro C, Gogate J, Jamieson C, Daly E, Zaki N, Kramer M. Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study. Psychiatry Res. 2020 Nov;293:113376. doi: 10.1016/j.psychres.2020.113376. Epub 2020 Aug 8. |
| IND Phase | Participants From Study NCT02417064:132; NCT02418585: 51; NCT02493868: 245; NCT02497287: 12; NCT02422186: 3; ESKETINTRD3006: 15 |
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| OP/MA Phase | 690 Participants From Study (NCT02417064:0; NCT02418585: 0; NCT02493868: 224; NCT02497287: 455; NCT02422186: 1; ESKETINTRD3006: 10) and 420 Participants from IND Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Esketamine Nasal Spray | Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams [mg] or 84 mg for participants less than [<] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to [>=] 65 years). Participants who entered the optimization and maintenance phase (OP/MA) from the IND phase of study NCT02782104 continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or ESKETINTRD3006 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered from study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in OP/MP. |
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| 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 | |||||||||||||||||||||||
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| Primary | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score | This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. The DET is a measure of psychomotor function and uses a well-validated simple reaction time. In this outcome measure, speed of performance of subjects (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranged from 2 to 3.3 log 10 milliseconds (msec). Lower score indicated better performance. Higher change from baseline indicated better performance. | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | log10 msec | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Primary | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score | This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. IDN test is a measure of visual attention (choice reaction time) and scored for speed of response (mean of the log10 transformed reaction times for correct responses). Total score ranged from 2 to 3.3 log 10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance. | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | log10 msec | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Primary | Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score | This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. OCL test is a measure of visual episodic memory and visual recall test scored using arcsine transformation of the percentage of correct responses (CR). The range for OCL is 0 to 100 percent (%) accuracy; presented as an arcsin transformation, the range is 0 to 1.57. Higher score indicated better performance. Higher change from baseline indicated better performance. | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Arcsine (sqrt of percentage of CR) | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Primary | Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score | The ONB is a measure of working memory and scored for speed of correct response (mean of the log10-transformed reaction times for correct responses). Total score ranged from 2 to 3.54 log10 msec. Lower score indicated better performance. Higher change from baseline indicated better performance. | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | log10 msec | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Primary | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score | This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. GMLT measures executive function; maze/sequencing test, scored for total number of errors. Total score ranged from 0 to 999 number of errors. Lower score indicated better performance. Higher change from baseline indicated better performance. | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Number of Errors | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Primary | Change From Study Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score | The HVLT-R measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0-12); the total number of true-positive errors (0-12); and the range of recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher total recall score indicated higher cognition. The range of the recognition discrimination index is -12 to 12. Higher score indicated better performance and higher change from baseline indicated better performance. | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Primary | Percentage of Participants Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score | C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and behavior, to assess whether participant experienced any of following: completed suicide, suicide attempt (response of "yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active SI with methods without intent to act or some intent to act, without or with specific plan and intent), any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Here, percentage of participants with >=1 positive behavior, participants with >=1 positive ideations; no event were reported. | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Number | Percentage of participants | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent. | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. | Posted | Count of Participants | Participants | IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months |
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| Primary | Change From Baseline in Heart Rate | Change from baseline (predose) in heart rate were reported. | Full analysis set included participants who received at least 1 dose of intranasal study medication in this study. | Posted | Mean | Standard Deviation | beats per minute | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Primary | Change From Baseline in Systolic and Diastolic Blood Pressure | Change from baseline in systolic and diastolic blood pressure were reported. | Full analysis set included participants who received at least 1 dose of intranasal study medication in this study. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Primary | Change From Baseline in Respiratory Rate | Change from baseline in respiratory rate were reported. | Full analysis set included participants who received at least 1 dose of intranasal study medication in this study. | Posted | Mean | Standard Deviation | breaths per minute | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Primary | Change From Baseline in Blood Oxygen Saturation | Change from baseline in blood oxygen saturation (predose) were reported. | Full analysis set included participants who received at least 1 dose of intranasal study medication in this study. | Posted | Mean | Standard Deviation | percentage of SpO2 | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Secondary | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score | MADRS measures depression severity, detects changes due to AD treatment. It consists of 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe conditions. Negative change in score indicates improvement. Missing data was imputed using last observation carried forward (LOCF) method. | Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a Scale | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Secondary | Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score | Change from baseline in PHQ-9 total score were reported. The PHQ-9 was a 9-item, patient-reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders. Each item was rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses were summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. | Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Secondary | Change From Baseline in Clinical Global Impression-severity (CGI-S) Score | Change from baseline in clinical global impression-severity (CGI-S) score were reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative change in score indicates improvement. | Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Median | Full Range | score on a scale | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Total Score | Change from baseline in SDS total score were reported. The SDS, a patient-reported outcome measure, was a 5 item questionnaire which had been widely used and accepted for assessment of functional and associated disability impairment. The first three items assessed disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items were summed to create a total score of 0-30 where a higher score indicated greater impairment. | Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Secondary | Change From Baseline in Participant-Reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Valuation Index Score (VAS) | Change from baseline in participant-reported health-related quality of life as assessed by EQ-5D-5L VAS was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. | Full analysis set included who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Secondary | Change From Baseline as Assessed by EQ 5D-5L: Sum Score | EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state. | Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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| Secondary | Change From Baseline in Participant- Reported Health Related Quality of Life Using the Quality of Life in Depression Scale (QLDS) | Change from baseline in participant- reported health related quality of life using the QLDS. The QLDS is a disease-specific validated patient-reported outcome (PRO) measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of "1" or "0". A score of "1" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition. | Full analysis set included who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months |
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IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months
All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication.
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 | Esketamine Nasal Spray (IND Phase) | Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams [mg] or 84 mg for participants less than [<] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to [>=] 65 years). | 1 | 458 | 5 | 458 | 318 | 458 |
| EG001 | Esketamine Nasal Spray (OP/MA Phase) | Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 were received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability. | 8 | 1,110 | 212 | 1,110 | 1,010 | 1,110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Coronary Artery Stenosis | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Myocardial Bridging | Congenital, familial and genetic disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Vertigo Positional | Ear and labyrinth disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Duodenal Perforation | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Gastric Polyps | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Hiatus Hernia | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Large Intestine Polyp | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Pancreatitis Relapsing | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Umbilical Hernia | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Death | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Bile Duct Stone | Hepatobiliary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Biliary Obstruction | Hepatobiliary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Anaphylactic Reaction | Immune system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Abscess Limb | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Cellulitis Staphylococcal | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Covid-19 Pneumonia | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Gastroenteritis Salmonella | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Gastrointestinal Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Large Intestine Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Necrotising Fasciitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Otitis Media Chronic | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Pharyngitis Streptococcal | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Postoperative Wound Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Staphylococcal Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Animal Bite | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Exposure During Pregnancy | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Face Injury | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Hand Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Multiple Injuries | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Muscle Rupture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Radius Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Thoracic Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Traumatic Intracranial Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Blood Pressure Diastolic Increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Myocardial Necrosis Marker Increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Facet Joint Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Intervertebral Disc Disorder | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Anal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
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| Breast Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
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| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
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| Clear Cell Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
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| Invasive Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
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| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
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| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
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| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
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| Oesophageal Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
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| Ovarian Germ Cell Teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pancreatic Neuroendocrine Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pituitary Tumour Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Small Intestine Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Carotid Artery Aneurysm | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Facial Paralysis | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Intracranial Aneurysm | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Metabolic Encephalopathy | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Occipital Neuralgia | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Device Breakage | Product Issues | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Adjustment Disorder | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Affect Lability | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Conversion Disorder | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Depression Suicidal | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Persistent Depressive Disorder | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Bladder Outlet Obstruction | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Renal Artery Stenosis | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Stress Urinary Incontinence | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Urethral Stenosis | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Urge Incontinence | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Urinary Bladder Polyp | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Breast Hyperplasia | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Epididymal Cyst | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Heavy Menstrual Bleeding | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Vaginal Prolapse | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Bronchitis Chronic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nasal Polyps | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nasal Septum Deviation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pneumothorax Spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Tonsillar Hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Vocal Cord Thickening | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Abdominoplasty | Surgical and medical procedures | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Female Sterilisation | Surgical and medical procedures | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Mammoplasty | Surgical and medical procedures | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Spinal Fusion Surgery | Surgical and medical procedures | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Aortic Dissection | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Circulatory Collapse | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hypertensive Emergency | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hypoaesthesia Oral | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Paraesthesia Oral | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Feeling Drunk | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dissociation | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Head | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 14, 2023 | Dec 29, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Unknown or Not Reported |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other |
|
| AUSTRIA |
|
| BELGIUM |
|
| BRAZIL |
|
| BULGARIA |
|
| CANADA |
|
| CZECH REPUBLIC |
|
| ESTONIA |
|
| FINLAND |
|
| FRANCE |
|
| GERMANY |
|
| HUNGARY |
|
| ITALY |
|
| LITHUANIA |
|
| MALAYSIA |
|
| MEXICO |
|
| POLAND |
|
| SLOVAKIA |
|
| SOUTH AFRICA |
|
| SOUTH KOREA |
|
| SPAIN |
|
| SWEDEN |
|
| TAIWAN |
|
| TURKEY |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability. |
|
|
| Esketamine Nasal Spray (OP/MA Phase) |
Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability. |
|
|
|
|
Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability.
|
|
| OG001 | Esketamine Nasal Spray (OP/MA Phase) | Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability. |
|
|
| OG001 | Esketamine Nasal Spray (OP/MA Phase) | Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability. |
|
|
|
|
|
|
|
|
|
|
|
|
Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability.
|
|
Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability.
|
|
| OG001 | Esketamine Nasal Spray (OP/MA Phase) | Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability. |
|
|
|
|
Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability. |
|
|
Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 were received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability. |
|
|
| Esketamine Nasal Spray (OP/MA Phase) |
Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability. |
|
|