Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04829318
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2021-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Norway'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Director Global Medical Affairs Lead', 'organization': 'Janssen-Cilag Limited'}, 'certainAgreement': {'otherDetails': '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 to allow for filing of a patent application.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.', 'eventGroups': [{'id': 'EG000', 'title': 'Esketamine + Oral AD', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\],and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 105 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.', 'otherNumAtRisk': 183, 'deathsNumAtRisk': 183, 'otherNumAffected': 145, 'seriousNumAtRisk': 183, 'deathsNumAffected': 1, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 32}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 50}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 81}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Dissociation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Rhinalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Percentage of participants with TEAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.'}, {'type': 'PRIMARY', 'title': 'Incidence Rate of Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.33', 'groupId': 'OG000', 'lowerLimit': '14.85', 'upperLimit': '20.23'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Incidence rate of TEAEs were reported. AE Incidence rate was defined as incidence rate per 100 patient-months = (number of participants with AE divided by sum of days at risk for AE) \\* 100\\*365.25/12. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'AEs per 100 patient-months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Percentage of participants with TESAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.'}, {'type': 'PRIMARY', 'title': 'Incidence Rate of Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.51'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Incidence rate of with TESAEs were reported. AE Incidence rate was defined as incidence rate per 100 patient-months = (number of participants with AE divided by sum of days at risk for AE) \\* 100\\*365.25/12. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent.', 'unitOfMeasure': 'AEs per 100 patient-months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.'}, {'type': 'PRIMARY', 'title': 'Percentage of of Participants With TEAEs Leading to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.51'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Percentage of participants with TEAEs leading to death were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.'}, {'type': 'PRIMARY', 'title': 'Incidence Rate of TEAEs Leading to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Incidence rate of TEAEs leading to death were reported. AE Incidence rate was defined as incidence rate per 100 patient-months = (number of participants with AE divided by sum of days at risk for AE) \\* 100\\*365.25/12. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'AEs per 100 patient-months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-emergent AEs of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'title': 'Sedation', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}]}]}, {'title': 'Dissociation', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}]}]}, {'title': 'Suicidality', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Suggestive of abuse potential', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}]}]}, {'title': 'Cystitis', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Percentage of participants with TEAEs of special interest were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious AEs. AEs of special interest were separately grouped by categories sedation, dissociation, suicidality, suggestive of abuse potential, cystitis and hepatic impairment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.'}, {'type': 'PRIMARY', 'title': 'Incidence Rate of Treatment-emergent AEs of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'title': 'Sedation', 'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Dissociation', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}]}]}, {'title': 'Suicidality', 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000'}]}]}, {'title': 'Suggestive of abuse potential', 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000'}]}]}, {'title': 'Cystitis', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'AE Incidence rate: incidence rate per 100 patient-months=(number of participants with AE divided by sum of days at risk for AE)\\* 100\\*365.25/12. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with intervention. SAE: AE resulting in any following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial intervention administration up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious AEs. AEs of special interest were grouped as categories sedation, dissociation, suicidality, suggestive of abuse potential, cystitis and hepatic impairment.', 'unitOfMeasure': 'AEs per 100 patient-months', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Suicidal Ideation and Behavior in Study 54135419TRD4010 as Assessed by Columbia-suicide Severity Rating Scale (C-SSRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'title': 'No suicidal ideation or behavior', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}]}]}, {'title': 'Suicidal ideation', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Suicidal behavior', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1 of Study 54135419TRD3013) up to Week 104 of study 54135419TRD4010 (up to Week 136)', 'description': 'Number of participants with suicidal ideation and behavior in study 54135419TRD4010 as assessed by C-SSRS score were reported. C-SSRS score: an assessment tool that evaluated suicidal ideation and behavior. Suicidal ideation (5 items): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior (5 items): preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide. Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior (0), Suicidal ideation (1 to 5), Suicidal behavior (6 to 10). Total score ranged from 0 to 10. Higher scores indicated more severe suicidal ideation and behavior.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With No Relapse and Without Discontinuation Until the End of the Prospective Observation Period at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1 of Study 54135419TRD3013) up to Week 104 of study 54135419TRD4010 (up to Week 136)', 'description': "Relapse was defined by any of the following: a) Worsening of depressive symptoms as indicated by Montgomery-Asberg Depression Rating Scale (MADRS) total score \\>=22 confirmed by 1 additional assessment of MADRS total score \\>=22 within the next 5 to 31 days. b) Any psychiatric hospitalization for: 1) worsening of depression, 2) suicide prevention or due to a suicide attempt for any of these events. c) Suicide attempt, completed suicide, or any other clinically relevant event determined per investigator's clinical judgment to be indicative of relapse of depressive illness, but for which participant was not hospitalized. MADRS scale consisted of 10 items, scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 to 60. Higher scores represented a more severe condition.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants in remission (MADRS total score of \\<=10) at any time point during Study 54135419TRD3013.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.9', 'spread': '8.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.8', 'spread': '7.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.5', 'spread': '7.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.8', 'spread': '7.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.3', 'spread': '7.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.6', 'spread': '6.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.4', 'spread': '7.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.5', 'spread': '7.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.5', 'spread': '8.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.7', 'spread': '7.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.9', 'spread': '7.41', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.9', 'spread': '7.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.6', 'spread': '7.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.0', 'spread': '6.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.1', 'spread': '7.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.4', 'spread': '7.52', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.2', 'spread': '7.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.6', 'spread': '6.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.8', 'spread': '6.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.7', 'spread': '7.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.6', 'spread': '6.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.4', 'spread': '6.78', 'groupId': 'OG000'}]}]}, {'title': 'Week 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.3', 'spread': '7.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.7', 'spread': '6.57', 'groupId': 'OG000'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.9', 'spread': '6.39', 'groupId': 'OG000'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-25.3', 'spread': '6.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': 'Change from baseline of study 54135419TRD3013 in Clinician-rated MADRS total score were reported. MADRS was a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items , scored from 0 (item is not present or normal) to 6 (severe or continuous presence of symptoms), summed up for a total possible score range of 0 to 60. Higher scores represented a more severe condition. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'title': 'Week 4: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.38', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.45', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.36', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 32: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.36', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.38', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.32', 'groupId': 'OG000'}]}]}, {'title': 'Week 56: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 60: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 64: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 68: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 72: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 76: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 80: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 88: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 92: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 96: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 100: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 104: Apparent Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.38', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 32: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 56: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 60: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 64: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 68: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 72: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 76: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 80: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 88: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 92: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 96: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 100: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 104: Reported Sadness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '1.07', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 32: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.07', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 56: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 60: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.32', 'groupId': 'OG000'}]}]}, {'title': 'Week 64: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 68: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 72: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 76: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 80: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 88: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 92: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 96: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 100: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 104: Inner Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.75', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': 'Week 32: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 56: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 60: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.62', 'groupId': 'OG000'}]}]}, {'title': 'Week 64: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'Week 68: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 72: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 76: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 80: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.84', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 88: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 92: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'Week 96: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 100: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 104: Reduced Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.78', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.75', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 32: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.78', 'groupId': 'OG000'}]}]}, {'title': 'Week 56: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 60: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 64: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 68: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 72: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 76: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.62', 'groupId': 'OG000'}]}]}, {'title': 'Week 80: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.78', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'Week 88: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 92: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 96: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 100: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 104: Reduced Appetite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 32: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 56: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 60: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 64: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 68: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 72: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 76: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 80: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 88: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'Week 92: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 96: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 100: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 104: Concentration Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.36', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 32: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 56: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 60: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 64: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 68: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 72: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 76: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 80: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.09', 'groupId': 'OG000'}]}]}, {'title': 'Week 88: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 92: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.09', 'groupId': 'OG000'}]}]}, {'title': 'Week 96: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 100: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 104: Lassitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Week 32: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 56: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 60: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 64: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 68: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 72: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 76: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 80: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 88: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 92: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 96: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 100: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 104: Inability to Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 32: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 56: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 60: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Week 64: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 68: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 72: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 76: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 80: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 88: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 92: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 96: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 100: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 104: Pessimistic Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 4: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.97', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 16: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Week 20: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 28: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 32: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 40: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.97', 'groupId': 'OG000'}]}]}, {'title': 'Week 44: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 56: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 60: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.97', 'groupId': 'OG000'}]}]}, {'title': 'Week 64: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 68: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 72: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 76: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 80: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.97', 'groupId': 'OG000'}]}]}, {'title': 'Week 88: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 92: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.97', 'groupId': 'OG000'}]}]}, {'title': 'Week 96: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Week 100: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 104: Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': 'Change from Baseline of Study 54135419TRD3013 in Clinician-rated MADRS Score Individual Items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts) were reported. MADRS was a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed up for a total possible score range of 0 to 60. Higher scores represent a more severe condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': "Change from Baseline of Study 54135419TRD3013 in CGI-S scale score were reported. The CGI-S provided an overall clinician-determined summary measure of the severity of the participant's illness that took 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 evaluated the severity of psychopathology on a scale of 1 to 7: where, 1 = normal (not ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participant's. Negative change in score indicated improvement. Participant's with a score of zero were considered missing.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analysis set included all subjects who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.0', 'spread': '5.80', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.9', 'spread': '5.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.9', 'spread': '5.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.2', 'spread': '5.53', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.3', 'spread': '5.46', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.3', 'spread': '5.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.5', 'spread': '5.25', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.3', 'spread': '5.71', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.6', 'spread': '6.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.5', 'spread': '5.55', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '5.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '5.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.4', 'spread': '5.55', 'groupId': 'OG000'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'spread': '5.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '5.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '5.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '5.60', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.1', 'spread': '5.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.2', 'spread': '5.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.1', 'spread': '5.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '5.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.2', 'spread': '5.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.5', 'spread': '5.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.2', 'spread': '5.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.7', 'spread': '4.78', 'groupId': 'OG000'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.7', 'spread': '4.97', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': "Change from Baseline of Study 54135419TRD3013 in PHQ 9-item total score were reported. The PHQ-9 was a validated 9-item, patient-reported outcome (PRO) measure to assess depressive symptoms. 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 a total score with a range of 0 to 27. Higher scores indicated greater severity of depressive symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analysis set included all participants who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.323', 'spread': '0.2479', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.320', 'spread': '0.2518', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.325', 'spread': '0.2379', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.322', 'spread': '0.2568', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.336', 'spread': '0.2444', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.331', 'spread': '0.2337', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.323', 'spread': '0.2415', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.335', 'spread': '0.2377', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.341', 'spread': '0.2512', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.333', 'spread': '0.2364', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.343', 'spread': '0.2576', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.345', 'spread': '0.2317', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.332', 'spread': '0.2374', 'groupId': 'OG000'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.348', 'spread': '0.2348', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.364', 'spread': '0.2322', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.350', 'spread': '0.2422', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.337', 'spread': '0.2546', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.354', 'spread': '0.2295', 'groupId': 'OG000'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.357', 'spread': '0.2440', 'groupId': 'OG000'}]}]}, {'title': 'Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.362', 'spread': '0.2375', 'groupId': 'OG000'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.350', 'spread': '0.2295', 'groupId': 'OG000'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.366', 'spread': '0.2385', 'groupId': 'OG000'}]}]}, {'title': 'Week 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.367', 'spread': '0.2275', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.375', 'spread': '0.2333', 'groupId': 'OG000'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.387', 'spread': '0.2321', 'groupId': 'OG000'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.387', 'spread': '0.2444', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of Study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': 'Change from baseline of Study 54135419TRD3013 in EQ-5D-5LQuestionnaire Score: health status index were reported. The EQ-5D-5L descriptive system comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions were divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems). The participant selected an answer for each of the 5 dimensions considering a response that best matched participant\'s health "today." Responses were used to generate health status index ranged from -0.594 to 1 (where 1 represents full health and negative values represent health states considered worse than dead). Positive change in score indicated improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analysis set included all subjects who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.35', 'spread': '20.595', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.24', 'spread': '21.939', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.74', 'spread': '20.884', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.98', 'spread': '20.523', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.85', 'spread': '20.143', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.83', 'spread': '20.438', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.23', 'spread': '21.006', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.30', 'spread': '21.119', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.99', 'spread': '19.901', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.56', 'spread': '21.210', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.19', 'spread': '21.259', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.57', 'spread': '21.717', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.60', 'spread': '21.419', 'groupId': 'OG000'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.90', 'spread': '20.828', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.47', 'spread': '20.423', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.49', 'spread': '20.352', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.82', 'spread': '20.195', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.84', 'spread': '20.252', 'groupId': 'OG000'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.90', 'spread': '19.866', 'groupId': 'OG000'}]}]}, {'title': 'Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.23', 'spread': '20.512', 'groupId': 'OG000'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.40', 'spread': '19.697', 'groupId': 'OG000'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.10', 'spread': '20.469', 'groupId': 'OG000'}]}]}, {'title': 'Week 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.87', 'spread': '20.228', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.75', 'spread': '19.759', 'groupId': 'OG000'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.66', 'spread': '18.887', 'groupId': 'OG000'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.75', 'spread': '19.356', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of Study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': "Change from baseline of Study 54135419TRD3013 in EQ-5D-5L: visual analogue scale were reported. EQ-VAS self-rating recorded the participant'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 indicated improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analysis set included all subjects who received at least 1 dose of esketamine anytime during the 54135419TRD4010 study. Here, 'N' (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}]}, {'type': 'Treated With Esketamine 28 mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Treated With Esketamine 56 mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'Treated With Esketamine 84 mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}]}, {'type': 'Treated With Oral AD', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Site terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 183 participants who completed the maintenance phase (Week 32) of study 54135419TRD3013 (NCT04338321) were enrolled and treated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Esketamine Nasal Spray + Oral Antidepressant (AD)', 'description': 'Participants (who received esketamine nasal spray in study 54135419TRD3013 \\[NCT04338321\\] through Week 30 \\[every 2 weeks dosing\\] or Week 31 \\[once weekly dosing\\], and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 10 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44.6', 'spread': '13.07', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-64 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants analyzed included participants who reported ethnicity.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants analyzed included participants who reported race.'}, {'title': 'Body mass index', 'classes': [{'title': 'Underweight <18.5 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Normal 18.5 to <25 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}, {'title': 'Overweight 25 to <30 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'Obese >=30 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants analyzed included participants who reported body mass index in kilograms per meter square (kg/m\\^2).'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-02', 'size': 2614964, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-11T21:22', 'hasProtocol': True}, {'date': '2024-09-09', 'size': 1800982, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-15T18:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2021-04-01', 'resultsFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-16', 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Percentage of participants with TEAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.'}, {'measure': 'Incidence Rate of Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Incidence rate of TEAEs were reported. AE Incidence rate was defined as incidence rate per 100 patient-months = (number of participants with AE divided by sum of days at risk for AE) \\* 100\\*365.25/12. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.'}, {'measure': 'Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Percentage of participants with TESAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent.'}, {'measure': 'Incidence Rate of Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Incidence rate of with TESAEs were reported. AE Incidence rate was defined as incidence rate per 100 patient-months = (number of participants with AE divided by sum of days at risk for AE) \\* 100\\*365.25/12. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent.'}, {'measure': 'Percentage of of Participants With TEAEs Leading to Death', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Percentage of participants with TEAEs leading to death were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.'}, {'measure': 'Incidence Rate of TEAEs Leading to Death', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Incidence rate of TEAEs leading to death were reported. AE Incidence rate was defined as incidence rate per 100 patient-months = (number of participants with AE divided by sum of days at risk for AE) \\* 100\\*365.25/12. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious adverse events.'}, {'measure': 'Percentage of Participants With Treatment-emergent AEs of Special Interest (AESIs)', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'Percentage of participants with TEAEs of special interest were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with intervention. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial administration of study intervention up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious AEs. AEs of special interest were separately grouped by categories sedation, dissociation, suicidality, suggestive of abuse potential, cystitis and hepatic impairment.'}, {'measure': 'Incidence Rate of Treatment-emergent AEs of Special Interest (AESIs)', 'timeFrame': 'From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)', 'description': 'AE Incidence rate: incidence rate per 100 patient-months=(number of participants with AE divided by sum of days at risk for AE)\\* 100\\*365.25/12. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with intervention. SAE: AE resulting in any following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurring at or after the initial intervention administration up to 30 days after last dose in Study 54135419TRD4010 was considered to be treatment emergent. TEAEs included both serious and non-serious AEs. AEs of special interest were grouped as categories sedation, dissociation, suicidality, suggestive of abuse potential, cystitis and hepatic impairment.'}, {'measure': 'Number of Participants With Suicidal Ideation and Behavior in Study 54135419TRD4010 as Assessed by Columbia-suicide Severity Rating Scale (C-SSRS) Score', 'timeFrame': 'Baseline (Day 1 of Study 54135419TRD3013) up to Week 104 of study 54135419TRD4010 (up to Week 136)', 'description': 'Number of participants with suicidal ideation and behavior in study 54135419TRD4010 as assessed by C-SSRS score were reported. C-SSRS score: an assessment tool that evaluated suicidal ideation and behavior. Suicidal ideation (5 items): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior (5 items): preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide. Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior (0), Suicidal ideation (1 to 5), Suicidal behavior (6 to 10). Total score ranged from 0 to 10. Higher scores indicated more severe suicidal ideation and behavior.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With No Relapse and Without Discontinuation Until the End of the Prospective Observation Period at Week 104', 'timeFrame': 'Baseline (Day 1 of Study 54135419TRD3013) up to Week 104 of study 54135419TRD4010 (up to Week 136)', 'description': "Relapse was defined by any of the following: a) Worsening of depressive symptoms as indicated by Montgomery-Asberg Depression Rating Scale (MADRS) total score \\>=22 confirmed by 1 additional assessment of MADRS total score \\>=22 within the next 5 to 31 days. b) Any psychiatric hospitalization for: 1) worsening of depression, 2) suicide prevention or due to a suicide attempt for any of these events. c) Suicide attempt, completed suicide, or any other clinically relevant event determined per investigator's clinical judgment to be indicative of relapse of depressive illness, but for which participant was not hospitalized. MADRS scale consisted of 10 items, scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 to 60. Higher scores represented a more severe condition."}, {'measure': 'Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': 'Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': 'Change from baseline of study 54135419TRD3013 in Clinician-rated MADRS total score were reported. MADRS was a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items , scored from 0 (item is not present or normal) to 6 (severe or continuous presence of symptoms), summed up for a total possible score range of 0 to 60. Higher scores represented a more severe condition. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts.'}, {'measure': 'Change From Baseline of Study 54135419TRD3013 in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) Score Individual Items', 'timeFrame': 'Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': 'Change from Baseline of Study 54135419TRD3013 in Clinician-rated MADRS Score Individual Items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts) were reported. MADRS was a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed up for a total possible score range of 0 to 60. Higher scores represent a more severe condition.'}, {'measure': 'Change From Baseline of Study 54135419TRD3013 in Clinical Global Impression -Severity (CGI-S) Scale Score', 'timeFrame': 'Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': "Change from Baseline of Study 54135419TRD3013 in CGI-S scale score were reported. The CGI-S provided an overall clinician-determined summary measure of the severity of the participant's illness that took 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 evaluated the severity of psychopathology on a scale of 1 to 7: where, 1 = normal (not ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participant's. Negative change in score indicated improvement. Participant's with a score of zero were considered missing."}, {'measure': 'Change From Baseline of Study 54135419TRD3013 in Patient Health Questionnaire (PHQ) 9-item Total Score', 'timeFrame': 'Baseline (Day 1 of study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': "Change from Baseline of Study 54135419TRD3013 in PHQ 9-item total score were reported. The PHQ-9 was a validated 9-item, patient-reported outcome (PRO) measure to assess depressive symptoms. 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 a total score with a range of 0 to 27. Higher scores indicated greater severity of depressive symptoms."}, {'measure': 'Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Health Status Index', 'timeFrame': 'Baseline (Day 1 of Study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': 'Change from baseline of Study 54135419TRD3013 in EQ-5D-5LQuestionnaire Score: health status index were reported. The EQ-5D-5L descriptive system comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions were divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems). The participant selected an answer for each of the 5 dimensions considering a response that best matched participant\'s health "today." Responses were used to generate health status index ranged from -0.594 to 1 (where 1 represents full health and negative values represent health states considered worse than dead). Positive change in score indicated improvement.'}, {'measure': 'Change From Baseline of Study 54135419TRD3013 in European Quality of Life (EuroQol) 5 Dimension 5-Level (EQ-5D-5L): Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline (Day 1 of Study 54135419TRD3013) up to weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104 of study 54135419TRD4010', 'description': "Change from baseline of Study 54135419TRD3013 in EQ-5D-5L: visual analogue scale were reported. EQ-VAS self-rating recorded the participant'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 indicated improvement."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment resistant depression'], 'conditions': ['Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to assess the long-term safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in participants who have completed 32 weeks of esketamine nasal spray treatment in Study 54135419TRD3013 (NCT04338321).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed the maintenance phase (Week 32) of Study 54135419TRD3013 (NCT04338321) and had esketamine nasal spray in combination with continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) administered through Week 30 (every 2 week dosing) or Week 31 (once weekly dosing) of Study 54135419TRD3013, and continues to be willing to be treated with esketamine nasal spray\n* Must, in the opinion of the investigator, be benefiting from continuation of esketamine nasal spray in combination with their current SSRI/SNRI based on efficacy and tolerability assessed on Day 1 of this study\n* Must be medically stable based on the investigator\'s judgment\n* A woman of childbearing potential must have a negative urine pregnancy test on Day 1\n* Male participants who are sexually active with a woman of childbearing potential must agree to the following during the intervention period and for at least 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention (that is, esketamine nasal spray), must fulfill the following criteria: must be practicing a highly effective method of contraception with his female partner, must use a condom if his partner is pregnant, and must agree not to donate sperm\n\nExclusion Criteria:\n\n* Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n* Completed Study 54135419TRD3013 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant\n* Has developed during participation in Study 54135419TRD3013 any of the following cardiovascular-related conditions where an increase in blood pressure or intracranial pressure poses a serious risk: cerebrovascular disease following stroke or transient ischemic attack, aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), intracerebral hemorrhage, coronary artery disease following myocardial infarction, unstable angina, or revascularization procedure (example, coronary angioplasty or bypass graft surgery), uncontrolled brady- or tachyarrhythmias that lead to hemodynamic instability, hemodynamically significant valvular heart disease such as mitral regurgitation, aortic stenosis, or aortic regurgitation or heart failure (New York Heart Association \\[NYHA\\] Class III-IV) of any etiology\n* Significant pulmonary insufficiency, including chronic obstructive pulmonary disease\n* Has homicidal ideation or intent, per the investigator\'s clinical judgment; or has suicidal ideation with some intent to act within 1 month prior to Day 1, per the investigator\'s clinical judgment; or based on the Columbia-suicide severity rating scale (C-SSRS) performed at Week 32 visit of Study 54135419TRD3013, corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation\n* Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention'}, 'identificationModule': {'nctId': 'NCT04829318', 'acronym': 'ESCAPE-LTE', 'briefTitle': 'A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag Ltd.'}, 'officialTitle': 'Open-label Long-Term Extension Study for Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment From Study 54135419TRD3013', 'orgStudyIdInfo': {'id': 'CR108992'}, 'secondaryIdInfos': [{'id': '2020-004291-18', 'type': 'EUDRACT_NUMBER'}, {'id': '54135419TRD4010', 'type': 'OTHER', 'domain': 'Janssen-Cilag Ltd.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esketamine', 'description': 'Participants who were randomly assigned to the esketamine arm in Study 54135419TRD3013 (NCT04338321), had esketamine nasal spray administered through Week 30 (every 2 weeks dosing) or Week 31 (once weekly dosing), completed the maintenance phase at Week 32 will continue to receive esketamine nasal spray once weekly or every 2 weeks along with serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. The duration of the study participation is 2 years or when esketamine is commercially available.', 'interventionNames': ['Drug: Esketamine', 'Drug: SSRI/SNRI']}], 'interventions': [{'name': 'Esketamine', 'type': 'DRUG', 'description': 'Esketamine will be self-administered as nasal spray.', 'armGroupLabels': ['Esketamine']}, {'name': 'SSRI/SNRI', 'type': 'DRUG', 'description': "Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the summary of product characteristics (SmPC) (or local equivalent, if applicable). 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