Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.\n\nCisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.', 'otherNumAffected': 48, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 42, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best Overall Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.\n\nCisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Not Assessed', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up', 'description': 'Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.\n\nCisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '51.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up', 'description': 'The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Progressive Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.\n\nCisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000', 'lowerLimit': '37.9', 'upperLimit': '56.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up', 'description': 'Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.\n\nCisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '48.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up', 'description': 'Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.\n\nCisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Patients with at least one CTC - Grade 1', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Patients with at least one CTC - Grade 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Patients with at least one CTC - Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Patients with at least one CTC - Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other auditory/hearing - Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other auditory/hearing - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other auditory/hearing - Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other auditory/hearing - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes - Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes - Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils/granulocytes - Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils/granulocytes - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils/granulocytes - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils/granulocytes - Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue - Grade 1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue - Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Weight loss - Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Weight loss - Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Weight loss - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Weight loss - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alopecia - Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Alopecia - Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Alopecia - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alopecia - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Rash/desquamation - Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Rash/desquamation - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Rash/desquamation - Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Rash/desquamation - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Anorexia - Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Anorexia - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Anorexia - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Anorexia - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea (without colostomy) - Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea (without colostomy) - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea (without colostomy) - Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea (without colostomy) - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Nausea - Grade 1', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Nausea - Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Nausea - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Nausea - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other Gastrointestinal - Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other Gastrointestinal - Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other Gastrointestinal - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other Gastrointestinal - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stomatitis/pharyngitis - Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stomatitis/pharyngitis - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stomatitis/pharyngitis - Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Stomatitis/pharyngitis - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting - Grade 1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase - Grade 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase - Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin - Grade 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serum glutamic oxaloacetic transaminase - Grade 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Serum glutamic oxaloacetic transaminase - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serum glutamic oxaloacetic transaminase - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serum glutamic oxaloacetic transaminase - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serum glutamic pyruvic transaminase - Grade 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Serum glutamic pyruvic transaminase - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serum glutamic pyruvic transaminase - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serum glutamic pyruvic transaminase - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Dizziness/lightheadedness - Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Dizziness/lightheadedness - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Dizziness/lightheadedness - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Dizziness/lightheadedness - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Headache - Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Headache - Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Headache - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Headache - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine - Grade 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine - Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Renal failure - Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Renal failure - Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Renal failure - Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Renal failure - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Renal/genitourinary - Other - Grade 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Renal/genitourinary - Other - Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Renal/genitourinary - Other - Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Renal/genitourinary - Other - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up', 'description': 'Grades range from 0 (no toxicity) to 4 (life-threatening or disabling).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.\n\nCisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Disease Progression or Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.\n\nCisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease Stage', 'classes': [{'title': 'Stage I - Tumor Limited to Ovaries', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Stage II - Pelvic Extension and/or Implants', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Stage IIIa - Microscopic Peritoneal Metastasis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Stage IIIb - Macroscopic Peritoneal Metastasis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Stage IIIc - Peritoneal Metastasis More Than 2 cm', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Stage IV - Distant Metastases', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group Performance Status Score', 'classes': [{'title': '0 - Fully Active', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': '1 - Ambulatory, Restricted Strenuous Activity', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': '2 - Ambulatory, No Work Activities', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '3 - Partially Confined to Bed, Limited Self Care', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '4 - Completely Disabled', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Postoperational Pathomorphological Diagnosis', 'classes': [{'title': 'Serous Cystadenocarcinoma', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'Mucinosa Cystadenocarcinoma', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Endometrioid Carcinoma', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'State of Patient Relative to Menopause', 'classes': [{'title': 'Fertile Period', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Post-Menopause', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time from Initial Diagnosis to Study Entry', 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'spread': '10.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-24', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2008-12-17', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-02-24', 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Overall Tumor Response', 'timeFrame': 'every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up', 'description': 'Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).'}], 'secondaryOutcomes': [{'measure': 'Duration of Response', 'timeFrame': 'every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up', 'description': 'The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.'}, {'measure': 'Time to Progressive Disease', 'timeFrame': 'every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up', 'description': 'Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.'}, {'measure': 'Time to Treatment Failure', 'timeFrame': 'every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up', 'description': 'Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.'}, {'measure': 'Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade', 'timeFrame': 'every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up', 'description': 'Grades range from 0 (no toxicity) to 4 (life-threatening or disabling).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250 mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECOG = 0-2\n* Operated patients\n* disease stage III-IV\n\nExclusion Criteria:\n\n* No prior chemotherapy or radiation therapy'}, 'identificationModule': {'nctId': 'NCT00191334', 'briefTitle': 'Gemcitabine in Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Phase II Study of Gemcitabine Plus Cisplatin as First-Line Therapy in Patients With Epithelial Ovarian Cancer', 'orgStudyIdInfo': {'id': '9340'}, 'secondaryIdInfos': [{'id': 'B9E-MW-S368'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: gemcitabine', 'Drug: cisplatin']}], 'interventions': [{'name': 'gemcitabine', 'type': 'DRUG', 'otherNames': ['LY188011', 'Gemzar'], 'description': '1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity', 'armGroupLabels': ['A']}, {'name': 'cisplatin', 'type': 'DRUG', 'description': '75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Irkutsk', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'city': 'Ivanovo', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 56.99988, 'lon': 40.97257}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Stavropol', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}