Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-03 @ 11:15 AM
Study NCT ID:
NCT02918318
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2016-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Global Medical Head', 'organization': 'Janssen Pharmaceutical K.K., Japan'}, '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Esk has transient dissociative effects that are difficult to blind, these specific events could have biased clinical staff who observed treatment sessions. To ensure an unbiased efficacy evaluation, remote, blinded MADRS raters were used.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 42 weeks', 'description': 'There was 1 participant who was randomized to the Esk 84 mg group but was dosed Esk 56 mg on Days 1 and 4, and Esk 28 mg on Day 8, then withdrew due to an adverse event on Day 11. This participant was summarized under the Esk 56 mg group for safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'Double Blind (DB): Esketamine 28 mg', 'description': 'Participants received intranasal esketamine 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received at least 1 dose of Esk during DB induction phase.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 33, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'DB: Esketamine 56 mg', 'description': 'Participants received intranasal esketamine 56 mg twice a week add-on to an oral AD for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received at least 1 dose of Esk DB induction phase.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 39, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DB: Esketamine 84 mg', 'description': 'Participants received intranasal esketamine 84 mg twice a week add-on to an oral AD for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received at least 1 dose of Esk during DB induction phase.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 39, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'DB: Placebo', 'description': 'Participants received intranasal placebo twice a week add-on to an oral AD for 4 weeks. Analysis was performed on safety analysis set- all randomized participants who received dose of internasal placebo during DB induction phase.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 34, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'DB Follow Up (FU): Esketamine 28 mg', 'description': 'Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD for 4 weeks. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 3, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'DB FU: Esketamine 56 mg', 'description': 'Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD in the DB FU phase. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 3, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'DB FU: Esketamine 84 mg', 'description': 'Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD in the DB FU phase. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 3, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'DB FU: Placebo', 'description': 'Participants who were non responders at the end of DB induction phase and entered the DB follow-up phase received only oral AD in the DB FU phase. Analysis was performed on follow-up analysis set- all participants who entered the follow-up phase and were evaluated for the safety.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 7, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Post-Treatment (PT) Phase: Esketamine 28 mg', 'description': 'Participants who were responders at the end of DB induction phase and entered in the PT phase received only oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'PT Phase: Esketamine 56 mg', 'description': 'Participants who were responders at the end of DB induction phase and entered in the PT phase received only oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'PT Phase: Esketamine 84 mg', 'description': 'Participants who were responders at the end of DB induction phase and entered in the PT phase received only an oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'PT Phase: Placebo', 'description': 'Participants who were responders at the end of DB induction phase and entered in the PT phase received only oral AD in the PT phase. Analysis was performed on safety analysis set- All participants who received at least 1 dose of oral AD during PT phase.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 7, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Open-Label (OL): Flexible Esketamine', 'description': 'Participants received flexible esketamine add-on to an oral AD during OL induction phase for 4 weeks. Analysis was performed on safety analysis set- All participants who received at least 1 dose of flexible Esk during OL induction phase.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 47, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG013', 'title': 'OL FU: Flexible Esketamine', 'description': 'Participants who received flexible esketamine add-on to an oral AD during OL induction phase were followed for 4 weeks in OL FU phase. Analysis was performed on follow-up analysis set- all participants who entered the OL follow-up phase and were evaluated for the safety.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 3, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Hyperacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Conjunctivitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Visual Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Hypoaesthesia Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 12}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Feeling Drunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 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'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Night Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}], 'seriousEvents': [{'term': 'Atrioventricular Block Second Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Cerebral Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.2', 'spread': '13.07', 'groupId': 'OG000'}, {'value': '-14.5', 'spread': '10.53', 'groupId': 'OG001'}, {'value': '-15.1', 'spread': '12.21', 'groupId': 'OG002'}, {'value': '-15.3', 'spread': '11.68', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.475', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.0', 'ciLowerLimit': '-5.77', 'ciUpperLimit': '3.70', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.25', 'statisticalMethod': 'Dunnett adjustment', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.504', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference of Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-4.32', 'ciUpperLimit': '5.47', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.33', 'statisticalMethod': 'Dunnett adjustment', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.482', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.9', 'ciLowerLimit': '-5.66', 'ciUpperLimit': '3.83', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.26', 'statisticalMethod': 'Dunnett adjustment', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) up to Day 28 (DB phase) induction', 'description': 'MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Negative change in score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS \\[DB\\]) included all randomized participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure (OM).'}, {'type': 'SECONDARY', 'title': 'DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}], 'classes': [{'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}, {'value': '9.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}, {'value': '3.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}, {'value': '18.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '13.9', 'groupId': 'OG001'}, {'value': '20.5', 'groupId': 'OG002'}, {'value': '29.7', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '35.3', 'groupId': 'OG001'}, {'value': '43.6', 'groupId': 'OG002'}, {'value': '37.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 2, 8, 15, 22 and 28 (DB induction phase)', 'description': 'A participant is defined as responder (yes=1 and no=0) at a given time point if the percent improvement from baseline in MADRS is greater than or equal to (\\>=) 50 percent (%). MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS (DB) included all randomized participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here 'n' (number analyzed) signifies number of participants who were evaluable for this OM at specified timepoints."}, {'type': 'SECONDARY', 'title': 'DB Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}], 'classes': [{'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7.5', 'groupId': 'OG002'}, {'value': '3.8', 'groupId': 'OG003'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '1.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}, {'value': '3.9', 'groupId': 'OG003'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}, {'value': '14.9', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}, {'value': '20.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 2, 8, 15, 22 and 28 (DB induction phase)', 'description': 'A participant was considered in remission at a given time point if the MADRS total score \\<=12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS (DB) included all randomized defined as all participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here 'n' (number analyzed) signifies number of participants who were evaluable for this OM at specified timepoints."}, {'type': 'SECONDARY', 'title': 'DB Induction Phase: Percentage of Participants Showing Onset of Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}], 'classes': [{'title': 'Onset of clinical response: Yes', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}, {'value': '6.3', 'groupId': 'OG003'}]}]}, {'title': 'Onset of clinical response: No', 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000'}, {'value': '97.4', 'groupId': 'OG001'}, {'value': '92.7', 'groupId': 'OG002'}, {'value': '93.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2 up to Day 28 (DB induction phase)', 'description': 'A participant was defined as having a clinical response if there was at least 50% improvement from baseline in the MADRS total score with onset by Day 2 that was maintained to Day 28 in DB induction phase. Participants were allowed one excursion (non-response) on Days 8, 15 or 22, provided the score is at least 25% improvement. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS (DB) included all randomized participants who received at least 1 dose of intranasal study agent during DB induction phase. Participants with missed assessments or discontinued early were not considered to have onset of clinical response. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'DB Induction Phase: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score up to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '1'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '0'}, {'value': '-1.0', 'groupId': 'OG002', 'lowerLimit': '-5', 'upperLimit': '0'}, {'value': '-1.0', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) up to Day 28 (DB induction pahse)', 'description': "CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. Values of 0 (not assessed) were excluded from analysis. CGI-S permits global evaluation of participant's condition at given time.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "FAS (DB) included all randomized participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'DB Induction Phase: Change From Baseline in Generalized Anxiety Disorder 7-Item Scale (GAD-7) up to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.2', 'spread': '4.94', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '5.05', 'groupId': 'OG001'}, {'value': '-8.1', 'spread': '5.67', 'groupId': 'OG002'}, {'value': '-7.7', 'spread': '5.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) up to Day 28 (DB induction phase)', 'description': 'GAD-7 was a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'DB Induction Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.6', 'spread': '8.68', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '7.94', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '8.93', 'groupId': 'OG002'}, {'value': '-7.0', 'spread': '7.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) to Day 28 (DB induction phase)', 'description': 'SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS (DB) included all randomized participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Posttreatment Phase: Time to Relapse in Participants With Remission (MADRS Total Score <=12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'comment': 'Upper limit of 90 % confidence internal was not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '26.0', 'upperLimit': 'NA'}, {'value': '52.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '80.0'}, {'value': '37.0', 'groupId': 'OG002', 'lowerLimit': '19.0', 'upperLimit': '71.0'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '22.0', 'upperLimit': '50.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From EndPoint (last post baseline assessment value during the DB induction phase [up to Day 28]) up to 24 weeks (posttreatment phase)', 'description': 'Time to relapse in participants with remission at the end of the double-blind phase was defined as the time between induction phase and the first documentation of a relapse event during the posttreatment phase. Relapse was defined as any of the following: 1) MADRS total score \\>= 22 for 2 consecutive assessments. The date of the second MADRS assessment was used for the date of relapse; 2) Hospitalization for worsening depression or any other clinically relevant event determined per clinical judgment to be suggestive of relapse of depressive illness like suicide attempt, completed suicide, or hospitalization for suicide prevention. If hospitalized for any of these events, start date of hospitalization was used as relapse date. If participant was not hospitalized, event date was used. 3) If both relapse criteria were met, earlier date was defined as date of relapse. Remission was defined as MADRS total score \\<=12.', 'unitOfMeasure': 'Days', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included participants with remit at the end of DB.'}, {'type': 'SECONDARY', 'title': 'Posttreatment Phase: Time to Relapse in Participants With Response (>=50% Reduction From Baseline in MADRS Total Score) But Who Are Not in Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '44.0'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '121.0'}, {'value': '79.5', 'groupId': 'OG002', 'lowerLimit': '16.0', 'upperLimit': '108.0'}, {'value': '91.0', 'comment': 'Upper limit of 90 % confidence internal was not estimable due to insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': '22.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From EndPoint (last post baseline assessment value during the DB induction phase [up to Day 28]) up to 24 weeks (posttreatment phase)', 'description': 'Time to relapse in participants with response (\\>=50% reduction from baseline in MADRS total score) but who are not in remission was reported. Relapse is defined as any of the following: 1) MADRS total score \\>= 22 for 2 consecutive assessments. The date of the second MADRS assessment was used for the date of relapse. 2)Hospitalization for worsening depression or any other clinically relevant event determined per clinical judgment to be suggestive of relapse of depressive illness like suicide attempt, completed suicide, or hospitalization for suicide prevention. If hospitalized for any of these events, start date of hospitalization was used as relapse date. If participant was not hospitalized, event date was used. 3) If both relapse criteria were met, earlier date was defined as date of relapse. Remission was defined as MADRS total score \\<=12.', 'unitOfMeasure': 'Days', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included participants with response (not remit) at the end of DB.'}, {'type': 'SECONDARY', 'title': 'Posttreatment Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 2, 4, 6, 8, 12, 16, 20 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.6', 'spread': '7.82', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '6.15', 'groupId': 'OG001'}, {'value': '-13.1', 'spread': '7.65', 'groupId': 'OG002'}, {'value': '-11.2', 'spread': '6.83', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12.9', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '2.75', 'groupId': 'OG001'}, {'value': '-13.6', 'spread': '7.34', 'groupId': 'OG002'}, {'value': '-9.8', 'spread': '5.84', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-17.7', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '3.61', 'groupId': 'OG001'}, {'value': '-14.6', 'spread': '5.53', 'groupId': 'OG002'}, {'value': '-12.0', 'spread': '4.39', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'spread': '14.42', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '1.53', 'groupId': 'OG001'}, {'value': '-15.3', 'spread': '7.15', 'groupId': 'OG002'}, {'value': '-11.4', 'spread': '6.02', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-20.5', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': '7.21', 'groupId': 'OG001'}, {'value': '-18.3', 'spread': '7.76', 'groupId': 'OG002'}, {'value': '-14.8', 'spread': '4.88', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-21.5', 'spread': '6.36', 'groupId': 'OG000'}, {'value': '-17.5', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '-12.5', 'spread': '21.92', 'groupId': 'OG002'}, {'value': '-15.8', 'spread': '1.89', 'groupId': 'OG003'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-22.0', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '-18.0', 'groupId': 'OG001'}, {'value': '-28.0', 'groupId': 'OG002'}, {'value': '-14.0', 'spread': '3.65', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-21.5', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '-16.0', 'groupId': 'OG001'}, {'value': '-28.0', 'groupId': 'OG002'}, {'value': '-14.8', 'spread': '3.59', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (DB induction phase), Weeks 2, 4, 6, 8, 12, 16, 20 and 24 (posttreatment phase)', 'description': 'SDS is a participant-reported outcome measure and is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30, where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when under productive. FAS (responders): All randomized participants who received at least 1 dose of intranasal study medication during DB induction phase and who were responders at the end of DB induction phase and entered posttreatment phase', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. Here, 'n' (number analyzed) signifies number of participants who were evaluable for this OM at specified timepoints."}, {'type': 'SECONDARY', 'title': 'OL Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine: Flexible Dose', 'description': 'OL induction phase: Responders from the DB induction phase who relapsed in the postreatment phase entered in an open label extension phase and received induction with flexible intransal Esketamine (either 28 mg, 56 mg, or 84 mg) along with oral AD for 4 weeks. OL Follow-up phase: All participants who entered the OL induction phase are followed up in OL follow-up phase for 4 weeks.'}], 'classes': [{'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 8, 15, 22 and 28 (OL induction phase)', 'description': 'A participant was considered in remission at a given time point if the MADRS total score \\<=12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS (OL) included all randomized participants who received at least 1 dose of intranasal study agent during the OL induction phase. Here 'n' (Number analyzed) signifies number of participants who were evaluable for this OM at specified timepoints."}, {'type': 'SECONDARY', 'title': 'OL Induction Phase: Change From Baseline (Prior to the First Dose of OL Induction Phase) in MADRS Total Score up to Endpoint OL Induction Phase (Last Post Baseline Assessment Value During the OL Induction Phase [OL: up to Day 28])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine: Flexible Dose', 'description': 'OL induction phase: Responders from the DB induction phase who relapsed in the postreatment phase entered in an open label extension phase and received induction with flexible intransal Esketamine (either 28 mg, 56 mg, or 84 mg) along with oral AD for 4 weeks. OL Follow-up phase: All participants who entered the OL induction phase are followed up in OL follow-up phase for 4 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '16.1', 'spread': '9.47', 'groupId': 'OG000'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-14.5', 'spread': '11.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Prior to first Dose of OL induction phase on Day 1) up to endpoint of OL induction phase (last post baseline assessment value during OL induction phase [OL: up to Day 28])', 'description': 'MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (OL) included all participants who received at least 1 dose of intranasal study agent during the OL induction phase.'}, {'type': 'SECONDARY', 'title': 'OL Induction Phase: Percentage of Participants With Severity of Psychopathology on the CGI-S Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Esketamine: Flexible Dose', 'description': 'OL induction phase: Responders from the DB induction phase who relapsed in the postreatment phase entered in an open label extension phase and received induction with flexible intransal Esketamine (either 28 mg, 56 mg, or 84 mg) along with oral AD for 4 weeks. OL Follow-up phase: All participants who entered the OL induction phase are followed up in OL follow-up phase for 4 weeks.'}], 'classes': [{'title': 'Normal, not at all ill:Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Normal, not at all ill:Endpoint', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Borderline mentally ill:Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Borderline mentally ill:Endpoint', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Mildly ill:Baseline', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Mildly ill:Endpoint', 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000'}]}]}, {'title': 'Moderately ill:Baseline', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Moderately ill:Endpoint', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}]}]}, {'title': 'Markedly ill:Baseline', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Markedly ill:Endpoint', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Severely ill:Baseline', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Severely ill:Endpoint', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Among the most extremely ill patients:Baseline', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Among the most extremely ill patients:Endpoint', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Prior to first dose of OL induction phase on Day 1), endpoint of OL induction phase (last post baseline assessment value during the OL induction phase [OL: up to Day 28])', 'description': "CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. CGI-S permits global evaluation of participant's condition at given time.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (OL) included all participants who received at least 1 dose of intranasal study agent during the OL induction phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'FG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'FG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}, {'id': 'FG004', 'title': 'Esketamine: Flexible Dose', 'description': 'OL induction phase: Responders from the DB induction phase who relapsed in the postreatment phase entered in an open label extension phase and received induction with flexible intransal Esketamine (either 28 mg, 56 mg, or 84 mg) along with oral AD for 4 weeks. OL Follow-up phase: All participants who entered the OL induction phase are followed up in OL follow-up phase for 4 weeks.'}], 'periods': [{'title': 'Double-blind Induction Phase: 4 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '80'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Responders', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '72'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Follow-up Phase: 4 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '53'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Posttreatment Phase: Up to 24 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Open Label Treatment Phase: 4 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}, {'title': 'Open Label Follow-up Phase: 4 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '202', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Esketamine 28 Milligrams (mg)', 'description': 'Double-blind (DB) induction phase: Participants received intranasal esketamine (Esk) 28 mg twice a week add-on to an oral antidepressant (AD) for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'BG001', 'title': 'Esketamine 56 mg', 'description': 'DB induction phase: Participants received intranasal Esk 56 mg twice a week add-on to a AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'BG002', 'title': 'Esketamine 84 mg', 'description': 'DB induction phase: Participants received intranasal Esk 84 mg twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for up to 24 weeks.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'DB induction phase: Participants received intranasal Esk placebo twice a week add-on to AD for 4 weeks. Responders (participants who had \\>=50% reduction from baseline in MADRS total score) at the end of the DB induction phase were eligible to proceed to the posttreatment. DB Follow-up Phase: Participants who did not respond (non-responders) in DB induction phase proceeded to the 4-week DB follow-up and received only oral AD. Posttreatment phase: Participants who were responders at the end of DB induction phase entered in posttreatment phase and received oral AD once daily for 24 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '9.97', 'groupId': 'BG000'}, {'value': '42.5', 'spread': '8.36', 'groupId': 'BG001'}, {'value': '41.9', 'spread': '10.26', 'groupId': 'BG002'}, {'value': '43.3', 'spread': '11.4', 'groupId': 'BG003'}, {'value': '43.4', 'spread': '10.35', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '202', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '202', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'JAPAN', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '202', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized participants who received at least 1 dose of intranasal study agent.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-21', 'size': 1775513, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-18T10:54', 'hasProtocol': True}, {'date': '2020-01-14', 'size': 1083554, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-08-18T10:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2016-09-27', 'resultsFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-24', 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28', 'timeFrame': 'Baseline (Day 1) up to Day 28 (DB phase) induction', 'description': 'MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Negative change in score indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score', 'timeFrame': 'Days 2, 8, 15, 22 and 28 (DB induction phase)', 'description': 'A participant is defined as responder (yes=1 and no=0) at a given time point if the percent improvement from baseline in MADRS is greater than or equal to (\\>=) 50 percent (%). MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.'}, {'measure': 'DB Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score', 'timeFrame': 'Days 2, 8, 15, 22 and 28 (DB induction phase)', 'description': 'A participant was considered in remission at a given time point if the MADRS total score \\<=12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.'}, {'measure': 'DB Induction Phase: Percentage of Participants Showing Onset of Clinical Response', 'timeFrame': 'Day 2 up to Day 28 (DB induction phase)', 'description': 'A participant was defined as having a clinical response if there was at least 50% improvement from baseline in the MADRS total score with onset by Day 2 that was maintained to Day 28 in DB induction phase. Participants were allowed one excursion (non-response) on Days 8, 15 or 22, provided the score is at least 25% improvement. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.'}, {'measure': 'DB Induction Phase: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score up to Day 28', 'timeFrame': 'Baseline (Day 1) up to Day 28 (DB induction pahse)', 'description': "CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. Values of 0 (not assessed) were excluded from analysis. CGI-S permits global evaluation of participant's condition at given time."}, {'measure': 'DB Induction Phase: Change From Baseline in Generalized Anxiety Disorder 7-Item Scale (GAD-7) up to Day 28', 'timeFrame': 'Baseline (Day 1) up to Day 28 (DB induction phase)', 'description': 'GAD-7 was a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21).'}, {'measure': 'DB Induction Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28', 'timeFrame': 'Baseline (Day 1) to Day 28 (DB induction phase)', 'description': 'SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive.'}, {'measure': 'Posttreatment Phase: Time to Relapse in Participants With Remission (MADRS Total Score <=12)', 'timeFrame': 'From EndPoint (last post baseline assessment value during the DB induction phase [up to Day 28]) up to 24 weeks (posttreatment phase)', 'description': 'Time to relapse in participants with remission at the end of the double-blind phase was defined as the time between induction phase and the first documentation of a relapse event during the posttreatment phase. Relapse was defined as any of the following: 1) MADRS total score \\>= 22 for 2 consecutive assessments. The date of the second MADRS assessment was used for the date of relapse; 2) Hospitalization for worsening depression or any other clinically relevant event determined per clinical judgment to be suggestive of relapse of depressive illness like suicide attempt, completed suicide, or hospitalization for suicide prevention. If hospitalized for any of these events, start date of hospitalization was used as relapse date. If participant was not hospitalized, event date was used. 3) If both relapse criteria were met, earlier date was defined as date of relapse. Remission was defined as MADRS total score \\<=12.'}, {'measure': 'Posttreatment Phase: Time to Relapse in Participants With Response (>=50% Reduction From Baseline in MADRS Total Score) But Who Are Not in Remission', 'timeFrame': 'From EndPoint (last post baseline assessment value during the DB induction phase [up to Day 28]) up to 24 weeks (posttreatment phase)', 'description': 'Time to relapse in participants with response (\\>=50% reduction from baseline in MADRS total score) but who are not in remission was reported. Relapse is defined as any of the following: 1) MADRS total score \\>= 22 for 2 consecutive assessments. The date of the second MADRS assessment was used for the date of relapse. 2)Hospitalization for worsening depression or any other clinically relevant event determined per clinical judgment to be suggestive of relapse of depressive illness like suicide attempt, completed suicide, or hospitalization for suicide prevention. If hospitalized for any of these events, start date of hospitalization was used as relapse date. If participant was not hospitalized, event date was used. 3) If both relapse criteria were met, earlier date was defined as date of relapse. Remission was defined as MADRS total score \\<=12.'}, {'measure': 'Posttreatment Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 2, 4, 6, 8, 12, 16, 20 and 24', 'timeFrame': 'Baseline (DB induction phase), Weeks 2, 4, 6, 8, 12, 16, 20 and 24 (posttreatment phase)', 'description': 'SDS is a participant-reported outcome measure and is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30, where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when under productive. FAS (responders): All randomized participants who received at least 1 dose of intranasal study medication during DB induction phase and who were responders at the end of DB induction phase and entered posttreatment phase'}, {'measure': 'OL Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score', 'timeFrame': 'Days 8, 15, 22 and 28 (OL induction phase)', 'description': 'A participant was considered in remission at a given time point if the MADRS total score \\<=12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.'}, {'measure': 'OL Induction Phase: Change From Baseline (Prior to the First Dose of OL Induction Phase) in MADRS Total Score up to Endpoint OL Induction Phase (Last Post Baseline Assessment Value During the OL Induction Phase [OL: up to Day 28])', 'timeFrame': 'Baseline (Prior to first Dose of OL induction phase on Day 1) up to endpoint of OL induction phase (last post baseline assessment value during OL induction phase [OL: up to Day 28])', 'description': 'MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.'}, {'measure': 'OL Induction Phase: Percentage of Participants With Severity of Psychopathology on the CGI-S Scale', 'timeFrame': 'Baseline (Prior to first dose of OL induction phase on Day 1), endpoint of OL induction phase (last post baseline assessment value during the OL induction phase [OL: up to Day 28])', 'description': "CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. CGI-S permits global evaluation of participant's condition at given time."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '35596932', 'type': 'DERIVED', 'citation': 'Ohnishi T, Wakamatsu A, Kobayashi H. Different symptomatic improvement pattern revealed by factor analysis between placebo response and response to Esketamine in treatment resistant depression. Psychiatry Clin Neurosci. 2022 Aug;76(8):377-383. doi: 10.1111/pcn.13379. Epub 2022 Jun 9.'}, {'pmid': '34696742', 'type': 'DERIVED', 'citation': 'Takahashi N, Yamada A, Shiraishi A, Shimizu H, Goto R, Tominaga Y. Efficacy and safety of fixed doses of intranasal Esketamine as an add-on therapy to Oral antidepressants in Japanese patients with treatment-resistant depression: a phase 2b randomized clinical study. BMC Psychiatry. 2021 Oct 25;21(1):526. doi: 10.1186/s12888-021-03538-y.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CR108227&attachmentIdentifier=4ef2af53-80a3-47f9-910f-3be69900934c&fileName=54135419TRD2005_(CR108227)_Additional_Results_Data_CH.pdf&versionIdentifier=', 'label': 'A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Subjects With Treatment Resistant Depression'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese participants with treatment-resistant depression (TRD), in improving depressive symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At the start of the screening phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI). In the case of single-episode MDD, the participant must be diagnosed with persistent depressive disorder, which meets criteria of major depressive episode for a continuous duration of greater than or equal to (\\>=)2 years, and the same physician from the site must be examining the participant for \\>=2 years continuously as a primary care physician of the participant\n* The participant's current major depressive episode, depression symptom severity (MADRS total score greater than or equal to \\[\\>=\\] 28 required), and antidepressant treatment response in the current depressive episode, must be confirmed using the SAFER interview\n* Participant must be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs (including blood pressure), pulse oximetry, and 12-lead electrocardiogram (ECG) performed in the screening phase\n* A woman of childbearing potential must have a negative highly sensitive serum Beta (β) human chorionic gonadotropin \\[β-hCG\\] test at the start of the screening phase and a negative urine pregnancy test must be obtained before the first dose of study drug on Day 1 of the double-blind induction phase prior to randomization\n* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies\n\nExclusion Criteria:\n\n* Participant has received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression\n* Participant previously received esketamine or ketamine as treatment for their MDD\n* Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase\n* Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase\n* Participant has a current or past history of seizure disorder (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)"}, 'identificationModule': {'nctId': 'NCT02918318', 'briefTitle': 'A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Pharmaceutical K.K.'}, 'officialTitle': 'A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Subjects With Treatment Resistant Depression', 'orgStudyIdInfo': {'id': 'CR108227'}, 'secondaryIdInfos': [{'id': '54135419TRD2005', 'type': 'OTHER', 'domain': 'Janssen Pharmaceutical K.K., Japan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Esketamine 28 milligram (mg)', 'description': 'Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes.', 'interventionNames': ['Drug: Intranasal esketamine (28 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Esketamine 56 mg', 'description': 'Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes.', 'interventionNames': ['Drug: Intranasal esketamine (56 mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Esketamine 84 mg', 'description': 'Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes.', 'interventionNames': ['Drug: Intranasal esketamine (84 mg)']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.', 'armGroupLabels': ['Placebo']}, {'name': 'Intranasal esketamine (28 mg)', 'type': 'DRUG', 'description': 'Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes.', 'armGroupLabels': ['Esketamine 28 milligram (mg)']}, {'name': 'Intranasal esketamine (56 mg)', 'type': 'DRUG', 'description': 'Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes.', 'armGroupLabels': ['Esketamine 56 mg']}, {'name': 'Intranasal esketamine (84 mg)', 'type': 'DRUG', 'description': 'Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes.', 'armGroupLabels': ['Esketamine 84 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Akita', 'country': 'Japan', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Fukui-shi', 'country': 'Japan', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Gunma', 'country': 'Japan'}, {'city': 'Hachinohe-shi', 'country': 'Japan'}, {'city': 'Hachioji-shi', 'country': 'Japan'}, {'city': 'Hirakata', 'country': 'Japan', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'city': 'Hiratsuka-shi', 'country': 'Japan'}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Ichikawa', 'country': 'Japan', 'geoPoint': {'lat': 35.73413, 'lon': 139.9065}}, {'city': 'Kanzaki-gun', 'country': 'Japan'}, {'city': 'Karatsu', 'country': 'Japan', 'geoPoint': {'lat': 33.4425, 'lon': 129.96972}}, {'city': 'Kashihara', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 135.61667}}, {'city': 'Kawasaki', 'country': 'Japan', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Kita-Azumi', 'country': 'Japan'}, {'city': 'Kita-ku', 'country': 'Japan', 'geoPoint': {'lat': 35.75264, 'lon': 139.73348}}, {'city': 'Kitakyushu', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kobe', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kodaira', 'country': 'Japan', 'geoPoint': {'lat': 35.72603, 'lon': 139.48508}}, {'city': 'Komoro-shi', 'country': 'Japan'}, {'city': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kure', 'country': 'Japan', 'geoPoint': {'lat': 34.23222, 'lon': 132.56658}}, {'city': 'Kurume-shi', 'country': 'Japan'}, {'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Maizuru', 'country': 'Japan', 'geoPoint': {'lat': 35.45, 'lon': 135.33333}}, {'city': 'Morioka', 'country': 'Japan', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'city': 'Nagakute', 'country': 'Japan', 'geoPoint': {'lat': 35.17325, 'lon': 137.05667}}, {'city': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Okayama', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okinawa', 'country': 'Japan', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Sapporo', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Setagaya-ku', 'country': 'Japan'}, {'city': 'Shibuya-ku', 'country': 'Japan'}, {'city': 'Shinjuku', 'country': 'Japan', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}, {'city': 'Shinjuku-ku', 'country': 'Japan'}, {'city': 'Takatsuki-shi', 'country': 'Japan'}, {'city': 'Toyoake', 'country': 'Japan', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'city': 'Ube', 'country': 'Japan', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}, {'city': 'Yokohama', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yonago', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 133.33333}}], 'overallOfficials': [{'name': 'Janssen Pharmaceutical K.K., Japan Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Pharmaceutical K.K.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Pharmaceutical K.K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}