Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-06 @ 12:35 PM
Study NCT ID:
NCT04147260
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2019-10-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of treatment until end of the 7 day follow up period, 15 days in total.', 'description': 'Treated Set (TS): The TS included all subjects who were randomized and treated with at least 1 dose of investigational product (IP) (BI 730357, placebo, or Ciprofloxacin). The TS was used for safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo QD/BID', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days or three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 7, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 9, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 11, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '500 mg BID Ciprofloxacin (Active Comparator))', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg in total) over 5 days from day 3 with a single dose on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Photosensitivity Index at 24 Hours Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.05'}, {'value': '1.01', 'groupId': 'OG001', 'lowerLimit': '0.95', 'upperLimit': '1.08'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.88', 'upperLimit': '1.12'}, {'value': '1.04', 'groupId': 'OG003', 'lowerLimit': '0.98', 'upperLimit': '1.11'}, {'value': '1.08', 'groupId': 'OG004', 'lowerLimit': '0.98', 'upperLimit': '1.17'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.09', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.068', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.04', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.067', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'pValue': '0.572', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.03', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.08', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.055', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.315', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.08', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.23', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.075', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.286', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.06', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.05', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.059', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.057', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.15', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.31', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.077', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 24 hours after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as ratio of the precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 24 hours)(i.e., MEDon-drug\\[millijoules (mJ)\\]/MEDbaseline\\[mJ\\]) and was hence unitless.\n\nMED was defined as lowest dose that produced uniform redness (C1) (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.', 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'PRIMARY', 'title': 'Photosensitivity Index at 24 Hours Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.21'}, {'value': '1.17', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '1.32'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.78', 'upperLimit': '1.22'}, {'value': '1.01', 'groupId': 'OG003', 'lowerLimit': '0.89', 'upperLimit': '1.13'}, {'value': '1.52', 'groupId': 'OG004', 'lowerLimit': '1.35', 'upperLimit': '1.69'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.23', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.153', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.01', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.124', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.51', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '-0.31', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.102', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.52', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.80', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.138', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.010', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.35', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '-0.09', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.59', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.93', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.173', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 24 hours after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules per centimetres-2 (J cm-2) (assessed in mw/cm2)), defined as ratio of the precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 24 hours)(i.e., MEDon-drug\\[Joules (J)\\]/MEDbaseline\\[J\\]) and hence unitless.\n\nMED was defined as lowest dose that produced uniform darkening (C2) (assessed in J for UVA).\n\nSubjects were exposed to series of 6 graded full range solar UVA exposures (C2), each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.', 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'SECONDARY', 'title': 'Photosensitivity Index (PI) at 10 Minutes Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.05'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.96', 'upperLimit': '1.04'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.82', 'upperLimit': '1.18'}, {'value': '1.06', 'groupId': 'OG003', 'lowerLimit': '0.97', 'upperLimit': '1.16'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '0.94', 'upperLimit': '1.06'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.03', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.044', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'pValue': '0.998', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.00', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.08', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.038', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.618', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.02', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.13', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.050', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.06', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.099', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'pValue': '0.451', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.06', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.23', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.081', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '1.000', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.00', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.22', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.110', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 10 minutes after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as ratio of the precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 10 minutes)(i.e., MEDon-drug\\[millijoules (mJ)\\]/MEDbaseline\\[mJ\\]) and was hence unitless.\n\nMED was defined as lowest dose that produced uniform redness (C1) (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.', 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'SECONDARY', 'title': 'Photosensitivity Index (PI) at 10 Minutes Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '1.29'}, {'value': '1.13', 'groupId': 'OG001', 'lowerLimit': '0.99', 'upperLimit': '1.28'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.67', 'upperLimit': '1.33'}, {'value': '1.29', 'groupId': 'OG003', 'lowerLimit': '1.12', 'upperLimit': '1.46'}, {'value': '1.03', 'groupId': 'OG004', 'lowerLimit': '0.81', 'upperLimit': '1.25'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.11', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.152', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'pValue': '0.446', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.10', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.36', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.131', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.972', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.01', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.35', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.29', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.182', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'pValue': '0.091', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.26', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.56', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.880', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.03', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.44', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.203', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 10 minutes after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as ratio of precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 10 minutes)(i.e., MEDon-drug\\[Joules (J)\\]/MEDbaseline\\[J\\]) and was hence unitless.\n\nMED defined as lowest dose that produced uniform darkening (C2) (assessed in J for UVA).\n\nSubjects were exposed to series of 6 graded full range solar UVA exposures (C2), each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.', 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'SECONDARY', 'title': 'Photosensitivity Index (PI) at 1 Hour Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '1.15'}, {'value': '0.99', 'groupId': 'OG001', 'lowerLimit': '0.95', 'upperLimit': '1.03'}, {'value': '1.04', 'groupId': 'OG002', 'lowerLimit': '0.85', 'upperLimit': '1.22'}, {'value': '1.08', 'groupId': 'OG003', 'lowerLimit': '0.99', 'upperLimit': '1.18'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '0.94', 'upperLimit': '1.06'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.08', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.043', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'pValue': '0.757', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.01', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.06', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.037', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.158', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.07', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.03', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.049', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.05', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.101', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'pValue': '0.330', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.08', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.25', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.083', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.754', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.04', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.19', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.113', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 1 hour after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as ratio of the precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 1 hour)(i.e., MEDon-drug\\[millijoules (mJ)\\]/MEDbaseline\\[mJ\\]) and was hence unitless.\n\nMED was defined as lowest dose that produced uniform redness (C1) (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.', 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'SECONDARY', 'title': 'Photosensitivity Index (PI) at 1 Hour Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '1.14'}, {'value': '1.22', 'groupId': 'OG001', 'lowerLimit': '1.10', 'upperLimit': '1.34'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.76', 'upperLimit': '1.24'}, {'value': '1.19', 'groupId': 'OG003', 'lowerLimit': '1.06', 'upperLimit': '1.32'}, {'value': '1.06', 'groupId': 'OG004', 'lowerLimit': '0.87', 'upperLimit': '1.24'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.31', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.128', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'pValue': '0.151', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.16', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.38', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.110', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.319', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.15', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.44', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.145', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.19', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.136', 'groupDescription': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Two-sided 90% CI with an acceptance range of -0.4 to 0.4'}, {'pValue': '0.246', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.13', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.36', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.112', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.704', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.06', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.36', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 1 hour after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), defined as ratio of precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 1 hour)(i.e. MEDon-drug\\[Joules (J)\\]/MEDbaseline\\[J\\]) and was hence unitless.\n\nMED defined as lowest dose that produced uniform darkening (C2) (assessed in J for UVA).\n\nSubjects were exposed to series of 6 graded full range solar UVA only exposures (C2), each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.', 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'SECONDARY', 'title': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 10 Minutes Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.12', 'groupId': 'OG000', 'lowerLimit': '-4.88', 'upperLimit': '11.12'}, {'value': '1.68', 'groupId': 'OG001', 'lowerLimit': '-2.68', 'upperLimit': '6.03'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-8.80', 'upperLimit': '8.80'}, {'value': '-1.96', 'groupId': 'OG003', 'lowerLimit': '-6.62', 'upperLimit': '2.69'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-6.53', 'upperLimit': '6.53'}]}]}], 'analyses': [{'pValue': '0.692', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.96', 'ciLowerLimit': '-11.92', 'ciUpperLimit': '7.99', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.929', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.630', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.96', 'ciLowerLimit': '-10.14', 'ciUpperLimit': '6.21', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.048', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '1.000', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.00', 'ciLowerLimit': '-11.07', 'ciUpperLimit': '11.07', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.482', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.751', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.44', 'ciLowerLimit': '-10.55', 'ciUpperLimit': '7.66', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.518', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.669', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.68', 'ciLowerLimit': '-6.17', 'ciUpperLimit': '9.52', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.894', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.546', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.12', 'ciLowerLimit': '-13.44', 'ciUpperLimit': '7.21', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.123', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline (Day -2) and at 10 minutes after irradiation on Day 8', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 10 minutes was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as lowest dose that produced uniform redness (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'SECONDARY', 'title': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 10 Minutes Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.19', 'groupId': 'OG000', 'lowerLimit': '-16.27', 'upperLimit': '30.66'}, {'value': '-1.02', 'groupId': 'OG001', 'lowerLimit': '-13.79', 'upperLimit': '11.75'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-20.32', 'upperLimit': '20.32'}, {'value': '-12.45', 'groupId': 'OG003', 'lowerLimit': '-23.20', 'upperLimit': '-1.69'}, {'value': '3.69', 'groupId': 'OG004', 'lowerLimit': '-15.46', 'upperLimit': '22.85'}]}]}], 'analyses': [{'pValue': '0.281', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-12.45', 'ciLowerLimit': '-35.44', 'ciUpperLimit': '10.54', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.385', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.092', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-16.14', 'ciLowerLimit': '-35.02', 'ciUpperLimit': '2.74', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.350', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.772', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.69', 'ciLowerLimit': '-21.88', 'ciUpperLimit': '29.27', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.662', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.539', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-8.21', 'ciLowerLimit': '-34.93', 'ciUpperLimit': '18.50', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.255', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.682', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.71', 'ciLowerLimit': '-27.74', 'ciUpperLimit': '18.31', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.424', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.817', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.50', 'ciLowerLimit': '-33.79', 'ciUpperLimit': '26.79', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.030', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline (Day -2) and at 10 minutes after irradiation on Day 8', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 10 minutes was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as lowest dose that produced uniform darkening (assessed in J for UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVA only exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'SECONDARY', 'title': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 1 Hour Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.50', 'groupId': 'OG000', 'lowerLimit': '-12.26', 'upperLimit': '3.26'}, {'value': '2.29', 'groupId': 'OG001', 'lowerLimit': '-1.94', 'upperLimit': '6.51'}, {'value': '-2.85', 'groupId': 'OG002', 'lowerLimit': '-12.36', 'upperLimit': '6.66'}, {'value': '-3.59', 'groupId': 'OG003', 'lowerLimit': '-8.62', 'upperLimit': '1.44'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-7.26', 'upperLimit': '7.26'}]}]}], 'analyses': [{'pValue': '0.891', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.73', 'ciLowerLimit': '-11.49', 'ciUpperLimit': '10.02', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.327', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.417', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.59', 'ciLowerLimit': '-12.42', 'ciUpperLimit': '5.25', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.375', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.633', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.85', 'ciLowerLimit': '-9.11', 'ciUpperLimit': '14.82', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.925', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.129', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.79', 'ciLowerLimit': '-2.05', 'ciUpperLimit': '15.62', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.384', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.548', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.29', 'ciLowerLimit': '-5.33', 'ciUpperLimit': '9.90', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.778', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.370', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.50', 'ciLowerLimit': '-5.51', 'ciUpperLimit': '14.52', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.970', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline (Day -2) and at 1 hour after irradiation on Day 8', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 1 hour was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as lowest dose that produced uniform redness (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'SECONDARY', 'title': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 1 Hour Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.82', 'groupId': 'OG000', 'lowerLimit': '-2.83', 'upperLimit': '30.47'}, {'value': '-12.82', 'groupId': 'OG001', 'lowerLimit': '-21.88', 'upperLimit': '-3.76'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-18.53', 'upperLimit': '18.53'}, {'value': '-9.30', 'groupId': 'OG003', 'lowerLimit': '-19.10', 'upperLimit': '0.50'}, {'value': '2.19', 'groupId': 'OG004', 'lowerLimit': '-11.40', 'upperLimit': '15.78'}]}]}], 'analyses': [{'pValue': '0.375', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-9.30', 'ciLowerLimit': '-30.26', 'ciUpperLimit': '11.66', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.379', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.185', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-11.49', 'ciLowerLimit': '-28.70', 'ciUpperLimit': '5.73', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.524', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.851', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.19', 'ciLowerLimit': '-21.12', 'ciUpperLimit': '25.50', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.544', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-26.64', 'ciLowerLimit': '-45.59', 'ciUpperLimit': '-7.69', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.405', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.071', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-15.01', 'ciLowerLimit': '-31.34', 'ciUpperLimit': '1.33', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.106', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.281', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-11.63', 'ciLowerLimit': '-33.13', 'ciUpperLimit': '9.86', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.664', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline (Day -2) and at 1 hour after irradiation on Day 8', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 1 hour was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as lowest dose that produced uniform darkening (assessed in J for UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVA only exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'SECONDARY', 'title': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 24 Hours Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.35', 'groupId': 'OG000', 'lowerLimit': '-2.80', 'upperLimit': '21.51'}, {'value': '1.35', 'groupId': 'OG001', 'lowerLimit': '-5.26', 'upperLimit': '7.97'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-9.59', 'upperLimit': '9.59'}, {'value': '-2.84', 'groupId': 'OG003', 'lowerLimit': '-7.92', 'upperLimit': '2.23'}, {'value': '-3.83', 'groupId': 'OG004', 'lowerLimit': '-11.15', 'upperLimit': '3.49'}]}]}], 'analyses': [{'pValue': '0.599', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.84', 'ciLowerLimit': '-13.69', 'ciUpperLimit': '8.00', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.370', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.824', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '-7.92', 'ciUpperLimit': '9.90', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.410', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.525', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.83', 'ciLowerLimit': '-15.90', 'ciUpperLimit': '8.23', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.973', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.250', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-8.00', 'ciLowerLimit': '-21.84', 'ciUpperLimit': '5.84', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.867', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.386', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.19', 'ciLowerLimit': '-6.74', 'ciUpperLimit': '17.12', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.919', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.097', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-13.19', 'ciLowerLimit': '-28.88', 'ciUpperLimit': '2.51', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.787', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline (Day -2) and at 24 hours after irradiation on Day 8', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 24 hours was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as lowest dose that produced uniform redness (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'type': 'SECONDARY', 'title': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 24 Hours Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'OG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'OG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.71', 'groupId': 'OG000', 'lowerLimit': '-3.52', 'upperLimit': '24.95'}, {'value': '-9.41', 'groupId': 'OG001', 'lowerLimit': '-17.16', 'upperLimit': '-1.67'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-12.21', 'upperLimit': '12.21'}, {'value': '0.99', 'groupId': 'OG003', 'lowerLimit': '-5.47', 'upperLimit': '7.46'}, {'value': '-27.91', 'groupId': 'OG004', 'lowerLimit': '-39.53', 'upperLimit': '-16.29'}]}]}], 'analyses': [{'pValue': '0.885', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '-12.83', 'ciUpperLimit': '14.81', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.842', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '28.90', 'ciLowerLimit': '17.55', 'ciUpperLimit': '40.25', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.619', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-27.91', 'ciLowerLimit': '-43.28', 'ciUpperLimit': '-12.54', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.610', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-20.13', 'ciLowerLimit': '-36.33', 'ciUpperLimit': '-3.92', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.041', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '0.011', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '18.50', 'ciLowerLimit': '4.53', 'ciUpperLimit': '32.46', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.931', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-38.62', 'ciLowerLimit': '-57.00', 'ciUpperLimit': '-20.25', 'pValueComment': 'P-value is for testing Least Squares Mean Difference=0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.118', 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect', 'nonInferiorityComment': 'Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and at 24 hours', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 24 hours was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as lowest dose that produced uniform darkening (assessed in J for UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVA only exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'FG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'FG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'FG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'FG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This is a partially blind, randomized, parallel group, placebo, and active comparator controlled Phase I clinical trial in healthy male and female subjects to evaluate the photosensitivity potential of BI 730357 compared with placebo and active comparator, and to assess the relationship between the photosensitivity response and pharmacokinetics of BI 730357.', 'preAssignmentDetails': 'All subjects were screened for eligibility to participants in the trial. Subjects attended specialist sites which would then ensure that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be assigned to treatment groups if any one of the specific entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '85', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo QD', 'description': 'Subjects received orally, four Placebo film-coated tablets once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 millilitres (mL) of water.'}, {'id': 'BG001', 'title': '400 mg QD BI 730357', 'description': 'Subjects received orally, four BI 730357 film-coated tablets of 100 miligrams (mg) each (400 mg in total) once per day (QD) over 8 days. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'BG002', 'title': 'Placebo BID', 'description': 'Subjects received orally, three Placebo film-coated tablets two times per day (BID) over 7 days with a single dose Placebo on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'BG003', 'title': '300 mg BID BI 730357', 'description': 'Subjects received orally, three BI 730357 film-coated tablets of 100 miligrams (mg) each, two times per day (BID) (2 x 300 mg = 600 mg daily dose in total) over 7 days with a single dose of 300 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'BG004', 'title': '500 mg Ciprofloxacin (Active Comparator)', 'description': 'Subjects received orally, one Ciprofloxacin film-coated tablet of 500 miligrams (mg) each, two times per days (BID) (2 x 500 mg = 1000 mg daily dose in total) over 5 days from day 3 with a single dose of 500 mg on Day 8. Medication administration was to take place at the same time every day within a deviation of no more than ±15 minutes together with about 240 mL of water.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '85', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '43.0', 'spread': '12.06', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '11.62', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '8.84', 'groupId': 'BG002'}, {'value': '39.7', 'spread': '12.84', 'groupId': 'BG003'}, {'value': '40.7', 'spread': '12.58', 'groupId': 'BG004'}, {'value': '39.4', 'spread': '11.84', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '85', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '85', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '85', 'groupId': 'BG005'}]}], '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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '80', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Unknown or Not Reported group is actually Other', 'unitOfMeasure': 'Participants'}, {'title': 'Minimum Erythema Dose (MED) at baseline under condition 1', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '79', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '30.60', 'spread': '6.328', 'groupId': 'BG000'}, {'value': '35.41', 'spread': '11.892', 'groupId': 'BG001'}, {'value': '36.84', 'spread': '7.910', 'groupId': 'BG002'}, {'value': '30.82', 'spread': '12.163', 'groupId': 'BG003'}, {'value': '30.78', 'spread': '12.280', 'groupId': 'BG004'}, {'value': '32.89', 'spread': '11.34', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'MED defined as lowest dose that produced uniform redness (condition 1) (assessed in mJ for UVB/UVA).\n\nCondition 1: under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2) Subjects were exposed to series of 6 graded full range solar UVB/UVA exposures, each 25% greater than previous dose. Outpatient irradiation and baseline MED testing for Irradiation Condition 1 occurred on Day -2. Two areas of back were defined for irradiation, followed by MED assessments at 24 hours (±10) minutes (Day -1) post irradiation.', 'unitOfMeasure': 'millijoules/squarecentimeter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}, {'title': 'Minimum Erythema Dose (MED) at baseline under condition 2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '79', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '21.60', 'spread': '4.04', 'groupId': 'BG000'}, {'value': '24.09', 'spread': '2.76', 'groupId': 'BG001'}, {'value': '25.10', 'spread': '0.00', 'groupId': 'BG002'}, {'value': '20.83', 'spread': '5.29', 'groupId': 'BG003'}, {'value': '22.58', 'spread': '4.64', 'groupId': 'BG004'}, {'value': '22.67', 'spread': '4.25', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'MED = lowest dose that produced uniform darkening (condition 2 C2) (in J for UVA). C2: UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with 2. assessment of erythema + local skin reactions at 25 Joules per centimetres-2 (J cm-2) (assessed in mw/cm2) Subjects exposed to series of 6 graded full range solar UVA exposures, each 25% greater than previous dose. Outpatient irradiation and baseline MED testing for Irradiation C2 occurred Day -2. Two areas of back defined for irradiation, MED assessments at 24 hours (±10) minutes (Day -1) post irradiation.', 'unitOfMeasure': 'Joules/squarecentimeter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full Analysis Set (FAS): This set included all subjects in the treated set (TS) who provided at least 1 photosensitivity endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of photosensitivity.'}], 'populationDescription': 'Treated Set (TS): The TS included all subjects who were randomized and treated with at least 1 dose of investigational product (IP) (BI 730357, placebo, or Ciprofloxacin). The TS was used for safety analyses.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-01', 'size': 627612, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-30T09:54', 'hasProtocol': True}, {'date': '2020-07-23', 'size': 5449617, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-30T09:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-12', 'studyFirstSubmitDate': '2019-10-30', 'resultsFirstSubmitDate': '2022-08-12', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-12', 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Photosensitivity Index at 24 Hours Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'timeFrame': 'At 24 hours after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as ratio of the precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 24 hours)(i.e., MEDon-drug\\[millijoules (mJ)\\]/MEDbaseline\\[mJ\\]) and was hence unitless.\n\nMED was defined as lowest dose that produced uniform redness (C1) (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.'}, {'measure': 'Photosensitivity Index at 24 Hours Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'timeFrame': 'At 24 hours after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules per centimetres-2 (J cm-2) (assessed in mw/cm2)), defined as ratio of the precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 24 hours)(i.e., MEDon-drug\\[Joules (J)\\]/MEDbaseline\\[J\\]) and hence unitless.\n\nMED was defined as lowest dose that produced uniform darkening (C2) (assessed in J for UVA).\n\nSubjects were exposed to series of 6 graded full range solar UVA exposures (C2), each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.'}], 'secondaryOutcomes': [{'measure': 'Photosensitivity Index (PI) at 10 Minutes Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'timeFrame': 'At 10 minutes after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as ratio of the precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 10 minutes)(i.e., MEDon-drug\\[millijoules (mJ)\\]/MEDbaseline\\[mJ\\]) and was hence unitless.\n\nMED was defined as lowest dose that produced uniform redness (C1) (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.'}, {'measure': 'Photosensitivity Index (PI) at 10 Minutes Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'timeFrame': 'At 10 minutes after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as ratio of precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 10 minutes)(i.e., MEDon-drug\\[Joules (J)\\]/MEDbaseline\\[J\\]) and was hence unitless.\n\nMED defined as lowest dose that produced uniform darkening (C2) (assessed in J for UVA).\n\nSubjects were exposed to series of 6 graded full range solar UVA exposures (C2), each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.'}, {'measure': 'Photosensitivity Index (PI) at 1 Hour Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'timeFrame': 'At 1 hour after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as ratio of the precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 1 hour)(i.e., MEDon-drug\\[millijoules (mJ)\\]/MEDbaseline\\[mJ\\]) and was hence unitless.\n\nMED was defined as lowest dose that produced uniform redness (C1) (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.'}, {'measure': 'Photosensitivity Index (PI) at 1 Hour Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'timeFrame': 'At 1 hour after irradiation on Day 8', 'description': 'Photosensitivity index (PI) under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), defined as ratio of precise Minimum erythema dose (MED)baseline to MEDon-drug at each respective post irradiation time point (i.e. 1 hour)(i.e. MEDon-drug\\[Joules (J)\\]/MEDbaseline\\[J\\]) and was hence unitless.\n\nMED defined as lowest dose that produced uniform darkening (C2) (assessed in J for UVA).\n\nSubjects were exposed to series of 6 graded full range solar UVA only exposures (C2), each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.'}, {'measure': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 10 Minutes Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'timeFrame': 'At baseline (Day -2) and at 10 minutes after irradiation on Day 8', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 10 minutes was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as lowest dose that produced uniform redness (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.'}, {'measure': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 10 Minutes Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'timeFrame': 'At baseline (Day -2) and at 10 minutes after irradiation on Day 8', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 10 minutes was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as lowest dose that produced uniform darkening (assessed in J for UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVA only exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 10 minutes after irradiation.'}, {'measure': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 1 Hour Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'timeFrame': 'At baseline (Day -2) and at 1 hour after irradiation on Day 8', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 1 hour was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as lowest dose that produced uniform redness (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.'}, {'measure': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 1 Hour Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'timeFrame': 'At baseline (Day -2) and at 1 hour after irradiation on Day 8', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 1 hour was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as lowest dose that produced uniform darkening (assessed in J for UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVA only exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 1 hour after irradiation.'}, {'measure': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 24 Hours Under Condition 1 (i.e., Under Full Range of UVB/UVA Exposure, Simulating Midday Summer Outdoor Sun Exposure)', 'timeFrame': 'At baseline (Day -2) and at 24 hours after irradiation on Day 8', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 24 hours was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 1 (C1)(i.e., under full range solar UVB/UVA (290 to 400 nm, UBV content \\~10%), simulating midday summer outdoor sun exposure (assessed in μw/cm2)), was defined as lowest dose that produced uniform redness (assessed in mJ for UVB/UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVB/UVA exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.'}, {'measure': 'Minimum Erythema Dose (MED) Percent Change From Baseline at 24 Hours Under Condition 2 (i.e., Under UVA Exposure Only, Simulating Indoor Sun Exposure Behind Window Glass)', 'timeFrame': 'At baseline and at 24 hours', 'description': 'The Minimum erythema dose (MED) percent change from baseline at 24 hours was calculated as follows: % change = (\\[MEDon-drug - MEDbaseline\\]/ MEDbaseline) x 100.\n\nMED under condition 2 (C2)(i.e., UVA only (320 to 400 nm, UVB content \\<0.03%), simulating indoor exposure behind window glass with a secondary assessment of erythema and local skin reactions at 25 Joules centimetres-2 (J cm-2) (assessed in mw/cm2)), was defined as lowest dose that produced uniform darkening (assessed in J for UVA).\n\nSubjects were exposed to a series of 6 graded full range solar UVA only exposures, each 25% greater than the previous dose.\n\nLight exposure occurred 2 hours (±10 minutes) after dose on Day 8 of either investigational product (IP) or placebo, and on-treatment photosensitivity assessments (determination of MEDon-drug + evaluation of erythema/local skin reactions) were performed at 24 hours after irradiation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the photosensitivity potential of BI 730357'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male and female subjects according to the assessment of the Investigator, based on a complete medical history, physical examination (including dermatological skin type assessment), vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests\n* 18 to 55 years old\n* BMI 18 to 35 kg/m (incl.)\n* Fitzpatrick skin type I, II, or III:\n\n * I Always burns easily, never tans\n * II Always burns easily, tans minimally\n * III Burns moderately, tans gradually\n* No ultraviolet exposure of the test areas 4 weeks prior to baseline photo testing\n* Normal skin response during preliminary photo testing.\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n* Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including blood pressure, pulse rate or ECG) deviating from normal and judged as clinically relevant by the Investigator.\n* Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance.\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders or any evidence of a concomitant disease judged as clinically relevant by the Investigator.\n* Major surgery (major according to the investigator's assessment) performed within 10 weeks prior to randomisation or planned within 2 months after screening.\n* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.\n* Active skin disorders on the back where photosensitivity testing will be performed.\n* Subjects who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.\n* Subjects not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the subject an unreliable trial participant).\n* Currently enrolled in another investigational device or drug trial, or less than 30 days (or 5 half-lives (whichever longer)) since ending another investigational drug trial.\n* Women who are pregnant, nursing, or who plan to become pregnant while in the trial.\n* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients).\n* History of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials.\n* History of hypersensitivity to sunlight or artificial source of intense light, especially UV light.\n* Chronic or acute infections which are of relevance in the opinion of the Investigator.\n* Positive result for HIV, HBV, and hepatitis C (Hep C) at screening.\n* History of TB or positive finding in IGRA.\n* Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the trial medication administration and until Day 7 post trial medication administration.\n* Positive drug screening.\n* Blood donation of more than 500 mL within 30 days prior to administration of trial medication or intended donation during the trial.\n* Intention to perform excessive physical activities within 4 days prior to administration of trial medication or contact sport during the entire trial and unwilling to avoid vigorous exercise for 7 days post dosing.\n* Inability to comply with dietary regimen of trial site.\n* Unwillingness to adhere to the rules of UV-light protection\n* Received a live vaccination within 12 weeks prior to randomisation (visit 2), or any plan to receive a live vaccination during the conduct of this trial.\n* Subjects with known prolongation of the QT interval, risk factors for QT prolongation or torsade de pointes."}, 'identificationModule': {'nctId': 'NCT04147260', 'briefTitle': 'Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Partially-blind, Randomized, Parallel Group, Placebo and Active Comparator-controlled Phase I Clinical Trial to Evaluate the Photosensitivity Potential of BI 730357', 'orgStudyIdInfo': {'id': '1407-0037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 730357 low dose', 'interventionNames': ['Drug: BI 730357']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ciprofloxacin', 'interventionNames': ['Drug: Ciprofloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'BI 730357 high dose', 'interventionNames': ['Drug: BI 730357']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo to match BI 730357']}], 'interventions': [{'name': 'BI 730357', 'type': 'DRUG', 'description': 'Film-coated tablet', 'armGroupLabels': ['BI 730357 high dose', 'BI 730357 low dose']}, {'name': 'Placebo to match BI 730357', 'type': 'DRUG', 'description': 'Film-coated tablet', 'armGroupLabels': ['Placebo']}, {'name': 'Ciprofloxacin', 'type': 'DRUG', 'description': 'Film-coated tablet', 'armGroupLabels': ['Ciprofloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07410', 'city': 'Fair Lawn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'TKL Research, Inc.', 'geoPoint': {'lat': 40.94038, 'lon': -74.13181}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:\n\n1\\. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}