Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-02 @ 2:39 AM
Study NCT ID:
NCT00806156
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2008-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalaffairs@nektar.com', 'title': 'Study Director', 'organization': 'Nektar Therapeutics'}, 'certainAgreement': {'otherDetails': "There are restrictions to the PI's rights to discuss or publish trial results.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the duration of the study (approximately 3 years and 11 months).', 'description': 'Safety Population=177 patients (n=38 NKTR-102 dose every 14 days; n=139 NKTR-102 dose every 21 days). All 177 participants experienced at least one adverse event, and 101 of them experienced at least one serious adverse event. Other Adverse Events section lists events occurring \\> 5% of patients.', 'eventGroups': [{'id': 'EG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 38, 'seriousNumAtRisk': 38, 'deathsNumAffected': 35, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 139, 'seriousNumAtRisk': 139, 'deathsNumAffected': 95, 'seriousNumAffected': 78}], 'otherEvents': [{'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 38, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 198, 'numAffected': 81}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 33, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 31, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 51, 'numAffected': 42}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 65, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 43, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 22, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 74, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 39, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 36, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 24, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 42, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 41, 'numAffected': 26}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 128, 'numAffected': 74}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 22, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 87, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 230, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 376, 'numAffected': 103}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 30, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 70, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 250, 'numAffected': 107}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 54, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 176, 'numAffected': 76}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 35, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 23, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 25, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 15, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 35, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 135, 'numAffected': 69}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 61, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 28, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 22, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'seriousEvents': [{'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Contrast media allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 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'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Respiratory 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'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'Primary Efficacy Population', 'description': 'The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '22.7'}, {'value': '14.4', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '22.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'The ORR was defined as the proportion of patients with a complete response (CR) or a partial response (PR) per RECIST 1.0 based upon the best response as assessed by the Investigator. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \\<10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. The analysis was performed for patients in the Primary Efficacy Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Best Overall Response by Gynecologic Cancer Intergroup (GCIG) Criteria: MITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'MITT Population', 'description': 'The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '47'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '33.3'}, {'value': '26', 'groupId': 'OG002', 'lowerLimit': '19.6', 'upperLimit': '33.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Best overall response was defined as the proportion of patients with a CR or a PR as assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and cancer antigen 125 (CA-125) criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the upper limit of normal (ULN) and within 2 weeks prior to starting treatment." Analysis was performed in MITT Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Best Overall Response by GCIG Criteria: Primary Efficacy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'Primary Efficacy Population', 'description': 'Patients in the MITT Population treated in q21d treatment schedule with platinum-resistant ovarian cancer, had received prior PLD therapy in a platinum-resistant setting or who were otherwise unable to receive further PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '34.4'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '34.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Primary Efficacy Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Best Overall Response by GCIG Criteria: Platinum-Refractory Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Platinum-Refractory Population', 'description': 'Patients in the MITT Population with a PFI ≤ 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '53.8'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '30.3'}, {'value': '18.5', 'groupId': 'OG002', 'lowerLimit': '9.9', 'upperLimit': '30'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Platinum-Refractory Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Best Overall Response by GCIG Criteria: Prior PLD Therapy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Prior PLD Population', 'description': 'Patients in the MITT Population treated in q14d and q21d treatment schedules, who subsequently progressed after receiving PLD therapy or who were otherwise unable to receive PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '52.4'}, {'value': '24.6', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '33.5'}, {'value': '24.6', 'groupId': 'OG002', 'lowerLimit': '17.5', 'upperLimit': '32.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Prior PLD Therapy Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Estimate of Progression-Free Survival (PFS): MITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'MITT Population', 'description': 'The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '6.7'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '5'}, {'value': '4.4', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'According to enhanced RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR an unambiguous increase in the sum of target lesion volumes with both 1) \\>20% increase in the sum of volumes (SOV) of all target lesions (taking as reference the nadir) and 2) greater than two times the variability of the measurements estimated by the sponsor and/or its designees.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Estimate of PFS: Primary Efficacy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites..'}, {'id': 'OG001', 'title': 'Primary Efficacy Population', 'description': 'Patients in the MITT Population treated in q21d treatment schedule with platinum-resistant ovarian cancer, had received prior PLD therapy in a platinum-resistant setting or who were otherwise unable to receive further PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '5'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Primary Efficacy Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Estimate of PFS: Platinum-Refractory Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Platinum-Refractory Population', 'description': 'Patients in the MITT Population with a PFI ≤ 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '15'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '4.6'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Platinum-Refractory Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Estimate of PFS: Prior PLD Therapy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Prior PLD Population', 'description': 'Patients in the MITT Population treated in q14d and q21d treatment schedules, who subsequently progressed after receiving PLD therapy or who were otherwise unable to receive PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '11.4'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '5'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Prior PLD Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Analysis of Duration of Overall Response (DoR): MITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'MITT Population', 'description': 'The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '8'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '10.9'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '10.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in MITT Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Analysis of DoR: Primary Efficacy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'Primary Efficacy Population', 'description': 'The primary efficacy population consisted of patients with platinum-resistant ovarian cancer in the modified intent-to-treat population (MITT) treated in q21d treatment schedule who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '13.2'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '13.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Primary Efficacy Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Analysis of DoR: Platinum-Refractory Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Platinum-Refractory Population', 'description': 'Patients in the MITT Population with a PFI ≤ 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '14.4'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '12.6'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '12.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Platinum-Refractory Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Analysis of DoR: Prior PLD Therapy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Prior PLD Population', 'description': 'Patients in the MITT Population treated in q14d and q21d treatment schedules, who subsequently progressed after receiving PLD therapy or who were otherwise unable to receive PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '14.4'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '10.9'}, {'value': '6.6', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Prior PLD Therapy Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: CA-125 Response Rate: MITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'MITT Population', 'description': 'The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '62.3'}, {'value': '34.9', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '44.6'}, {'value': '36.9', 'groupId': 'OG002', 'lowerLimit': '28.9', 'upperLimit': '45.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in MITT Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: CA-125 Response Rate: Primary Efficacy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'Primary Efficacy Population', 'description': 'The primary efficacy population only included subjects treated in the NKTR-102 q21d treatment arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '23.3', 'upperLimit': '43.8'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '23.3', 'upperLimit': '43.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Primary Efficacy Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: CA-125 Response Rate: Platinum-Refractory Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Platinum-Refractory Population', 'description': 'Patients in the MITT Population with a PFI ≤ 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '69.2'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '35.6'}, {'value': '23.5', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '37.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Platinum-Refractory Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: CA-125 Response Rate: Prior PLD Therapy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Prior PLD Population', 'description': 'Patients in the MITT Population treated in q14d and q21d treatment schedules, who subsequently progressed after receiving PLD therapy or who were otherwise unable to receive PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '67.7'}, {'value': '33.7', 'groupId': 'OG001', 'lowerLimit': '24.3', 'upperLimit': '44.1'}, {'value': '34.5', 'groupId': 'OG002', 'lowerLimit': '25.7', 'upperLimit': '44.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Prior PLD Therapy Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Clinical Benefit Rate: MITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'MITT Population', 'description': 'The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000', 'lowerLimit': '39.5', 'upperLimit': '72.9'}, {'value': '50.8', 'groupId': 'OG001', 'lowerLimit': '41.9', 'upperLimit': '59.6'}, {'value': '52.1', 'groupId': 'OG002', 'lowerLimit': '44.3', 'upperLimit': '59.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in MITT Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Clinical Benefit Rate: Primary Efficacy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'Primary Efficacy Population', 'description': 'The primary efficacy population consisted of patients with platinum-resistant ovarian cancer in the modified intent-to-treat population (MITT) treated in q21d treatment schedule who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '60.9'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '60.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Primary Efficacy Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Clinical Benefit Rate: Platinum-Refractory Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Platinum-Refractory Population', 'description': 'Patients in the MITT Population with a PFI ≤ 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '86.1'}, {'value': '38.5', 'groupId': 'OG001', 'lowerLimit': '25.3', 'upperLimit': '53'}, {'value': '43.1', 'groupId': 'OG002', 'lowerLimit': '30.8', 'upperLimit': '56'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Platinum-Refractory Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Clinical Benefit Rate: Prior PLD Therapy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Prior PLD Population', 'description': 'Patients in the MITT Population treated in q14d and q21d treatment schedules, who subsequently progressed after receiving PLD therapy or who were otherwise unable to receive PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000', 'lowerLimit': '29.9', 'upperLimit': '80.2'}, {'value': '50.9', 'groupId': 'OG001', 'lowerLimit': '41.3', 'upperLimit': '60.4'}, {'value': '51.5', 'groupId': 'OG002', 'lowerLimit': '42.6', 'upperLimit': '60.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Prior PLD Therapy Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Analysis of Overall Survival (OS): MITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'MITT Population', 'description': 'The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '16.7'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '12.2'}, {'value': '10.6', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '12.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in MITT Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Analysis of OS: Primary Efficacy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'Primary Efficacy Population', 'description': 'The primary efficacy population consisted of patients with platinum-resistant ovarian cancer in the modified intent-to-treat population (MITT) treated in q21d treatment schedule who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '13.1'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '13.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Primary Efficacy Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Analysis of OS: Platinum-Refractory Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Platinum-Refractory Population', 'description': 'Patients in the MITT Population with a PFI ≤ 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '21.6'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '12.2'}, {'value': '9.4', 'groupId': 'OG002', 'lowerLimit': '5.8', 'upperLimit': '12.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Platinum-Refractory Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: Kaplan-Meier Analysis of OS: Prior PLD Therapy Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Prior PLD Population', 'description': 'Patients in the MITT Population treated in q14d and q21d treatment schedules, who subsequently progressed after receiving PLD therapy or who were otherwise unable to receive PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '16.7'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '13.1'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '9.5', 'upperLimit': '12.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Prior PLD Therapy Population.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: ORR by RECIST: MITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'MITT Population', 'description': 'The modified intent-to-treat (MITT) Population for the q14d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q14d treatment regimen. The MITT Population for the q21d Arm included all platinum-resistant ovarian cancer patients who were enrolled to the q21d treatment regimen. The MITT Population included those patients who had undergone radiographic tumor measurement evaluation at Baseline with measurable tumors, and were enrolled and received at least one dose (or partial dose) of study drug. Platinum-resistant patients had a platinum-free interval (PFI) ≤ 6 months. PFI was defined as the time to recurrence/progression from last dose of the prior platinum-based therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '38.2'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '22.4'}, {'value': '16.6', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '23'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the MITT Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: ORR by RECIST: Prior PLD Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'OG002', 'title': 'Prior PLD Population', 'description': 'Patients in the MITT Population treated in q14d and q21d treatment schedules, who subsequently progressed after receiving PLD therapy or who were otherwise unable to receive PLD therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '45.6'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '22.8'}, {'value': '15.4', 'groupId': 'OG002', 'lowerLimit': '9.7', 'upperLimit': '22.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the PLD Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Secondary: ORR by RECIST: Platinum-Refractory Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites and shortly thereafter included in Protocol Amendment 1.0 dated 26 Mar 2009.'}, {'id': 'OG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites and shortly thereafter included in Protocol Amendment 1.0 dated 26 Mar 2009.'}, {'id': 'OG002', 'title': 'Platinum-Refractory Population', 'description': 'Patients in the MITT Population with a PFI ≤ 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '45.4'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '28.1'}, {'value': '15.4', 'groupId': 'OG002', 'lowerLimit': '7.6', 'upperLimit': '26.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the Platinum-Refractory Population.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Received at least one dose of study treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.'}, {'id': 'FG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '139'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'Did not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Consent withdrawn by subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The study began with an initial Simon two-stage design in which patients were randomized 1:1 into one of two treatment schedules (145 mg/m2 q14d or q21d). During Stage 1, 20 patients were to be enrolled and treated in each schedule (q14d or q21d). If at least 1 response was observed in 20 evaluable patients within a treatment schedule, the treatment schedule would progress to Stage 2, where an additional 15 patients were to be enrolled for a total of 35 patients in the treatment schedule.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'BG001', 'title': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.\n\nNote: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '12.14', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '11.49', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '11.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2014-08-12', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2008-12-04', 'dispFirstSubmitQcDate': '2014-08-12', 'resultsFirstSubmitDate': '2018-01-30', 'studyFirstSubmitQcDate': '2008-12-09', 'dispFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-18', 'studyFirstPostDateStruct': {'date': '2008-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'The ORR was defined as the proportion of patients with a complete response (CR) or a partial response (PR) per RECIST 1.0 based upon the best response as assessed by the Investigator. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \\<10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. The analysis was performed for patients in the Primary Efficacy Population.'}], 'secondaryOutcomes': [{'measure': 'Secondary: Best Overall Response by Gynecologic Cancer Intergroup (GCIG) Criteria: MITT Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Best overall response was defined as the proportion of patients with a CR or a PR as assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and cancer antigen 125 (CA-125) criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the upper limit of normal (ULN) and within 2 weeks prior to starting treatment." Analysis was performed in MITT Population.'}, {'measure': 'Secondary: Best Overall Response by GCIG Criteria: Primary Efficacy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Primary Efficacy Population.'}, {'measure': 'Secondary: Best Overall Response by GCIG Criteria: Platinum-Refractory Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Platinum-Refractory Population.'}, {'measure': 'Secondary: Best Overall Response by GCIG Criteria: Prior PLD Therapy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Prior PLD Therapy Population.'}, {'measure': 'Secondary: Kaplan-Meier Estimate of Progression-Free Survival (PFS): MITT Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'According to enhanced RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR an unambiguous increase in the sum of target lesion volumes with both 1) \\>20% increase in the sum of volumes (SOV) of all target lesions (taking as reference the nadir) and 2) greater than two times the variability of the measurements estimated by the sponsor and/or its designees.'}, {'measure': 'Secondary: Kaplan-Meier Estimate of PFS: Primary Efficacy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Primary Efficacy Population.'}, {'measure': 'Secondary: Kaplan-Meier Estimate of PFS: Platinum-Refractory Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Platinum-Refractory Population.'}, {'measure': 'Secondary: Kaplan-Meier Estimate of PFS: Prior PLD Therapy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Prior PLD Population.'}, {'measure': 'Secondary: Kaplan-Meier Analysis of Duration of Overall Response (DoR): MITT Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in MITT Population.'}, {'measure': 'Secondary: Kaplan-Meier Analysis of DoR: Primary Efficacy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Primary Efficacy Population.'}, {'measure': 'Secondary: Kaplan-Meier Analysis of DoR: Platinum-Refractory Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Platinum-Refractory Population.'}, {'measure': 'Secondary: Kaplan-Meier Analysis of DoR: Prior PLD Therapy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Prior PLD Therapy Population.'}, {'measure': 'Secondary: CA-125 Response Rate: MITT Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in MITT Population.'}, {'measure': 'Secondary: CA-125 Response Rate: Primary Efficacy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Primary Efficacy Population.'}, {'measure': 'Secondary: CA-125 Response Rate: Platinum-Refractory Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Platinum-Refractory Population.'}, {'measure': 'Secondary: CA-125 Response Rate: Prior PLD Therapy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Prior PLD Therapy Population.'}, {'measure': 'Secondary: Clinical Benefit Rate: MITT Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in MITT Population.'}, {'measure': 'Secondary: Clinical Benefit Rate: Primary Efficacy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Primary Efficacy Population.'}, {'measure': 'Secondary: Clinical Benefit Rate: Platinum-Refractory Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Platinum-Refractory Population.'}, {'measure': 'Secondary: Clinical Benefit Rate: Prior PLD Therapy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Prior PLD Therapy Population.'}, {'measure': 'Secondary: Kaplan-Meier Analysis of Overall Survival (OS): MITT Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in MITT Population.'}, {'measure': 'Secondary: Kaplan-Meier Analysis of OS: Primary Efficacy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Primary Efficacy Population.'}, {'measure': 'Secondary: Kaplan-Meier Analysis of OS: Platinum-Refractory Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Platinum-Refractory Population.'}, {'measure': 'Secondary: Kaplan-Meier Analysis of OS: Prior PLD Therapy Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Prior PLD Therapy Population.'}, {'measure': 'Secondary: ORR by RECIST: MITT Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the MITT Population.'}, {'measure': 'Secondary: ORR by RECIST: Prior PLD Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the PLD Population.'}, {'measure': 'Secondary: ORR by RECIST: Platinum-Refractory Population', 'timeFrame': 'Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)', 'description': 'The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the Platinum-Refractory Population.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tumor', 'Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '28935273', 'type': 'DERIVED', 'citation': 'Rustin G, Vergote I, Micha JP, Duska LR, Reed N, Bendell J, Spitz D, Dark G, Hoch U, Tagliaferri M, Hannah AL, Garcia AA. A multicenter, open-label, expanded phase 2 study to evaluate the safety and efficacy of etirinotecan pegol, a polymer conjugate of irinotecan, in women with recurrent platinum-resistant or refractory ovarian cancer. Gynecol Oncol. 2017 Nov;147(2):276-282. doi: 10.1016/j.ygyno.2017.08.026. Epub 2017 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced platinum-resistant ovarian cancer.\n\nApproximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102 will be administered at a dose level of 145 mg/m\\^2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. After the initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer\n2. Inoperable metastatic or locally advanced ovarian cancer\n3. Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of last dose of most recent platinum drug\n4. Platinum-resistant patients who have progressed after receiving PLD (Doxil/Caelyx)therapy in a platinum-resistant setting or who otherwise unable to receive PLD therapy.\n5. Diseases must be measurable as defined by RECIST in at least 1 lesion not previously irradiated.\n6. ECOG performance score of 0 or 1.\n7. Adequate organ and bone marrow functions at Screening.\n\nExclusion Criteria:\n\n1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) and have not recovered to NCI-CTCAE grade 1 toxicity prior to Day 1 of Cycle 1\n2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2 weeks prior to Day 1 of Cycle 1\n3. Patients who have received CYP3A4 inducers or inhibitors.\n4. Patients who have received any treatment with a camptothecin derivative (eg. irinotecan, topotecan, SN38 investigational agents, etc.).\n5. Patients with CNS metastases.'}, 'identificationModule': {'nctId': 'NCT00806156', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nektar Therapeutics'}, 'officialTitle': 'A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 When Given on a Q14 Day or a Q21 Day Schedule in Patients With Metastatic or Locally Advanced Platinum-Resistant Ovarian Cancer', 'orgStudyIdInfo': {'id': '08-PIR-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NKTR-102 q14d', 'description': 'NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.', 'interventionNames': ['Drug: NKTR-102 q14d']}, {'type': 'EXPERIMENTAL', 'label': 'NKTR-102 q21d', 'description': 'NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \\[± 2 days\\] cycle at a dose of 170 mg/m\\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\\^2 for the remainder of the patients.', 'interventionNames': ['Drug: NKTR-102 q21d']}], 'interventions': [{'name': 'NKTR-102 q14d', 'type': 'DRUG', 'description': 'NKTR-102 given on a q14 day schedule', 'armGroupLabels': ['NKTR-102 q14d']}, {'name': 'NKTR-102 q21d', 'type': 'DRUG', 'description': 'NKTR-102 given on a q21 day schedule', 'armGroupLabels': ['NKTR-102 q21d']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92346', 'city': 'Highland', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site - Higland', 'geoPoint': {'lat': 34.12834, 'lon': -117.20865}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site - Newport Beach', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site - West Palm Beach', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigator Site - Iowa City', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigator Site - Lansing', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site - 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Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Investigator Site - Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Investigator Site - Wilrijk', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'city': 'Middlesex', 'state': 'Northwood', 'country': 'United Kingdom', 'facility': 'Investigator Site - Middlesex', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}, {'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Investigator Site - Coventry', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Investigator Site - Dundee', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'G12 OYN', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Investigator Site - Glasgow', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Investigator Site - Newcastle Upon Tyne', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nektar Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nektar Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}