Viewing Study NCT00788957

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Ignite Creation Date: 2025-12-24 @ 6:35 PM
Ignite Modification Date: 2026-01-01 @ 10:41 AM
Study NCT ID: NCT00788957
Status: COMPLETED
Last Update Posted: 2024-08-07
First Post: 2008-10-23
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Belgium', 'Canada', 'France', 'Italy', 'Poland', 'Russia', 'Spain', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077544', 'term': 'Panitumumab'}, {'id': 'C545764', 'term': 'ganitumab'}, {'id': 'C524459', 'term': 'rilotumumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bobby.Reddy@Immunitybio.com', 'phone': '855-797-9277', 'title': 'Sandeep Bobby Reddy, Chief Medical Officer', 'organization': 'ImmunityBio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Part 3 of the study did not reach the accrual goal. Only 24 out of the 42 planned subjects received treatment in Part 3 of the study.'}}, 'adverseEventsModule': {'timeFrame': 'All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 8, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 42, 'seriousNumAtRisk': 48, 'deathsNumAffected': 32, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 47, 'seriousNumAtRisk': 48, 'deathsNumAffected': 35, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 44, 'seriousNumAtRisk': 46, 'deathsNumAffected': 37, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'Part 3: Rilotumumab', 'description': 'Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'deathsNumAffected': 8, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Part 3: Ganitumab', 'description': 'Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 8, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': 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'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 48, 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'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colorectal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Capillary leak syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercreatininaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Number of Participants With Dose-limiting Toxicities (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 weeks', 'description': 'A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The first 6 DLT evaluable participants, including participants who received at least 2 doses of panitumumab and rilotumumab as scheduled (ie, Week 1 and 3) and have a minimum 28 days follow-up for safety or, have received at least 1 dose of panitumumab and rilotumumab and had a DLT within the first 28 days on study.'}, {'type': 'PRIMARY', 'title': 'Part 2: Percentage of Participants With an Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG001', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG002', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '35.0'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '18.7', 'upperLimit': '46.3'}, {'value': '22', 'groupId': 'OG002', 'lowerLimit': '10.9', 'upperLimit': '36.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set (enrolled participants who received at least one dose of respective investigational product in the corresponding parts of the study) with measurable baseline disease.'}, {'type': 'SECONDARY', 'title': 'Duration of Response - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG001', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG002', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'comment': 'Not estimable as number of responding subjects and number with events was too small to calculate upper confidence interval.', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': 'NA'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '5.6'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '5.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'Time from the confirmed objective response to disease progression per the modified RECIST v1.0 criteria.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with confirmed response'}, {'type': 'SECONDARY', 'title': 'Time to Response - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG001', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG002', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.5'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.7'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'Time from the first dose of investigational product to the date of first confirmed objective response. Calculated only for subject with a confirmed objective response', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with confirmed response'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG001', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG002', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '71'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '83'}, {'value': '61', 'groupId': 'OG002', 'lowerLimit': '45', 'upperLimit': '75'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'The incidence of confirmed objective response or stable disease. Stable disease cannot be established prior to study day 49 (calculated from the date of first dose of investigational product), ie, the earliest protocol scheduled tumor assessment', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG001', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG002', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '5.3'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '5.4'}, {'value': '5.3', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '5.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'On-treatment Progression-free Survival (PFS) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG001', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG002', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '5.3'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '5.4'}, {'value': '5.3', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '5.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Up to 56 weeks.', 'description': 'Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death during the treatment period (from the first to last dose of investigational product). Radiographic progression within 28 days since last dose of study therapy (last component of combination therapy) up to the initiation of another anti-tumor therapy, including the Part 3 treatment, if applicable, or death within 28 days since last dose of study therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG001', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG002', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper CIs are not estimable due to small number of subjects with events in time period.', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper CIs are not estimable due to small number of subjects with events in time period.', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper CIs are not estimable due to small number of subjects with events in time period.', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'The interval in months from the first dose of investigational product to the date of death.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cmin, Cmax of Panitumumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'title': 'Cmin', 'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '105'}]}]}, {'title': 'Cmax', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000', 'lowerLimit': '166', 'upperLimit': '276'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': 'Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Cmin, Cmax, for Rilotumumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'title': 'Cmin', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000', 'lowerLimit': '86.7', 'upperLimit': '171'}]}]}, {'title': 'Cmax', 'categories': [{'measurements': [{'value': '306', 'groupId': 'OG000', 'lowerLimit': '264', 'upperLimit': '488'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': 'Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Cmin for Panitumumab - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG001', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG002', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'title': 'Week 3', 'categories': [{'measurements': [{'value': '19.8', 'spread': '80.3', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '73.5', 'groupId': 'OG001'}, {'value': '17.2', 'spread': '56.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '34.8', 'spread': '58.9', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '52.5', 'groupId': 'OG001'}, {'value': '29.8', 'spread': '55.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '39.9', 'spread': '62.2', 'groupId': 'OG000'}, {'value': '45.2', 'spread': '50.4', 'groupId': 'OG001'}, {'value': '37.4', 'spread': '54.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '63.5', 'spread': '43.0', 'groupId': 'OG000'}, {'value': '63.4', 'spread': '45.2', 'groupId': 'OG001'}, {'value': '51.4', 'spread': '63.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '82.1', 'spread': '28.2', 'groupId': 'OG000'}, {'value': '62.1', 'spread': '44.3', 'groupId': 'OG001'}, {'value': '54.8', 'spread': '53.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmin = minimum drug concentration during a dosing interval', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population Measure of dispersion is %CV'}, {'type': 'SECONDARY', 'title': 'Cmax for Panitumumab - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG001', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG002', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '114', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '124', 'spread': '26.4', 'groupId': 'OG001'}, {'value': '118', 'spread': '34.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '149', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '154', 'spread': '29.0', 'groupId': 'OG001'}, {'value': '139', 'spread': '24.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '165', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '172', 'spread': '32.3', 'groupId': 'OG001'}, {'value': '150', 'spread': '26.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '166', 'spread': '30.8', 'groupId': 'OG000'}, {'value': '180', 'spread': '29.6', 'groupId': 'OG001'}, {'value': '167', 'spread': '23.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '201', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '199', 'spread': '25.7', 'groupId': 'OG001'}, {'value': '192', 'spread': '31.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '196', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '207', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '187', 'spread': '22.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmax = maximum observed drug concentration during a dosing interval', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population Measure of dispersion is %CV'}, {'type': 'SECONDARY', 'title': 'Cmin for Rilotumumab - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'title': 'Week 3', 'categories': [{'measurements': [{'value': '70.1', 'spread': '41.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '119', 'spread': '31.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '143', 'spread': '27.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '186', 'spread': '40.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '181', 'spread': '36.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmin = minimum drug concentration during a dosing interval', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population Measure of dispersion is %CV'}, {'type': 'SECONDARY', 'title': 'Cmax for Rilotumumab - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '239', 'spread': '29.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '316', 'spread': '28.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '357', 'spread': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '397', 'spread': '24.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '453', 'spread': '23.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '421', 'spread': '26.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmax = maximum observed drug concentration during a dosing interval', 'unitOfMeasure': 'μg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population Measure of dispersion is %CV'}, {'type': 'SECONDARY', 'title': 'Cmin for Ganitumab - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'title': 'Week 3', 'categories': [{'measurements': [{'value': '19.8', 'spread': '51.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '24.4', 'spread': '55.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '28.9', 'spread': '54.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '38.8', 'spread': '61.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '39.7', 'spread': '58.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmin = minimum drug concentration during a dosing interval', 'unitOfMeasure': 'μg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population Measure of dispersion is %CV'}, {'type': 'SECONDARY', 'title': 'Cmax for Ganitumab - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '218', 'spread': '30.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '240', 'spread': '25.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '244', 'spread': '29.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '279', 'spread': '35.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '274', 'spread': '28.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '276', 'spread': '22.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmax = maximum observed drug concentration during a dosing interval', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population Measure of dispersion is %CV'}, {'type': 'SECONDARY', 'title': 'Total Anti-Panitumumab Antibody Incidence - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG001', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'OG002', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}, {'value': '17.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of any study drug and before 120 days of last dose of study drugs; up to 1 year, eight months', 'description': 'Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by either Biacore or ELISA.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Anti-AMG 102 Antibody Incidence - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.', 'description': 'Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects having AMG-102 treatment in part 2 were measured for antibody incidence.'}, {'type': 'SECONDARY', 'title': 'Total Anti-AMG 479 Antibody Incidence - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.', 'description': 'Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects having AMG-479 treatment in part 2 were measured for antibody incidence.'}, {'type': 'SECONDARY', 'title': 'AUC for Rilotumumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '2300', 'groupId': 'OG000', 'lowerLimit': '2020', 'upperLimit': '3540'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 Days', 'description': 'AUC = area under the drug concentration-time curve during a dosing interval', 'unitOfMeasure': 'day•μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'AUC for Panitumumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}], 'classes': [{'categories': [{'measurements': [{'value': '1200', 'groupId': 'OG000', 'lowerLimit': '987', 'upperLimit': '1890'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 Days', 'description': 'AUC = area under the drug concentration-time curve during a dosing interval', 'unitOfMeasure': 'day•μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'FG001', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'FG002', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'FG003', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'FG004', 'title': 'Part 3: Rilotumumab', 'description': 'Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.'}, {'id': 'FG005', 'title': 'Part 3: Ganitumab', 'description': 'Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.'}], 'periods': [{'title': 'Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed the safety follow-up visit', 'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Part 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Completed the safety follow-up visit at the end of the study', 'groupId': 'FG001', 'numSubjects': '6'}, {'comment': 'Completed the safety follow-up visit', 'groupId': 'FG002', 'numSubjects': '4'}, {'comment': 'Completed the safety follow-up visit', 'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'On-study at time of data cut-off', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Part 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Completed the safety follow-up visit', 'groupId': 'FG004', 'numSubjects': '4'}, {'comment': 'Completed the safety follow-up visit', 'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'On-study at time of data cut-off', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First patient enrolled 27 October 2008; last patient enrolled 05 February 2010. In Part 1, participants with wild-type KRAS metastatic colorectal cancer received open-label rilotumumab and panitumumab to identify a tolerable dose of rilotumumab for Part 2 of the study. Participants enrolled in Part 1 were not eligible for randomization in Part 2.', 'preAssignmentDetails': 'In Part 2 participants were randomized in a 1:1:1 ratio to the 3 double-blinded treatment arms. In Part 3, participants randomized to Panitumumab Alone in Part 2 and with disease progression or intolerability were re-randomized 1:1 into 2 double-blind groups.\n\nClinically significant laboratory findings were considered adverse events, so the protocol endpoint "Incidence of all AEs and clinical laboratory abnormalities" was not analyzed separately but was included in the AE data'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '177', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'BG001', 'title': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'BG002', 'title': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'BG003', 'title': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.'}, {'id': 'BG004', 'title': 'Part 3: Rilotumumab', 'description': 'Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.'}, {'id': 'BG005', 'title': 'Part 3: Ganitumab', 'description': 'Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Part 1 Participants', 'categories': [{'measurements': [{'value': '56.5', 'spread': '13.8', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'groupId': 'BG005'}, {'value': '56.5', 'spread': '13.8', 'groupId': 'BG006'}]}]}, {'title': 'Part 2 Participants', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '7.5', 'groupId': 'BG002'}, {'value': '62.0', 'spread': '9.7', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'groupId': 'BG005'}, {'value': '59.7', 'spread': '10.6', 'groupId': 'BG006'}]}]}, {'title': 'Part 3 Participants', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'groupId': 'BG003'}, {'value': '54.8', 'spread': '13.9', 'groupId': 'BG004'}, {'value': '52.0', 'spread': '11.3', 'groupId': 'BG005'}, {'value': '53.5', 'spread': '12.6', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '75', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '102', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '171', 'groupId': 'BG006'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Hispanic/Latino was collected as Race Category.', 'unitOfMeasure': 'participants'}, {'title': 'Subjects With Wild-Type KRAS Metastatic Colorectal Cancer', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '177', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set, including participants who received at least one dose of respective investigational product in the corresponding parts of the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-06-17', 'size': 1486245, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-18T19:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'dispFirstSubmitDate': '2014-03-26', 'completionDateStruct': {'date': '2010-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2008-10-23', 'dispFirstSubmitQcDate': '2014-03-26', 'resultsFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2008-11-10', 'dispFirstPostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-23', 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants With Dose-limiting Toxicities (DLT)', 'timeFrame': '7 weeks', 'description': 'A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator'}, {'measure': 'Part 2: Percentage of Participants With an Objective Response', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response - Part 2', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'Time from the confirmed objective response to disease progression per the modified RECIST v1.0 criteria.'}, {'measure': 'Time to Response - Part 2', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'Time from the first dose of investigational product to the date of first confirmed objective response. Calculated only for subject with a confirmed objective response'}, {'measure': 'Disease Control Rate - Part 2', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'The incidence of confirmed objective response or stable disease. Stable disease cannot be established prior to study day 49 (calculated from the date of first dose of investigational product), ie, the earliest protocol scheduled tumor assessment'}, {'measure': 'Progression-free Survival (PFS) - Part 2', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death'}, {'measure': 'On-treatment Progression-free Survival (PFS) - Part 2', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Up to 56 weeks.', 'description': 'Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death during the treatment period (from the first to last dose of investigational product). Radiographic progression within 28 days since last dose of study therapy (last component of combination therapy) up to the initiation of another anti-tumor therapy, including the Part 3 treatment, if applicable, or death within 28 days since last dose of study therapy.'}, {'measure': 'Overall Survival - Part 2', 'timeFrame': 'From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.', 'description': 'The interval in months from the first dose of investigational product to the date of death.'}, {'measure': 'Cmin, Cmax of Panitumumab', 'timeFrame': '14 days', 'description': 'Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval'}, {'measure': 'Cmin, Cmax, for Rilotumumab', 'timeFrame': '14 days', 'description': 'Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval'}, {'measure': 'Cmin for Panitumumab - Part 2', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmin = minimum drug concentration during a dosing interval'}, {'measure': 'Cmax for Panitumumab - Part 2', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmax = maximum observed drug concentration during a dosing interval'}, {'measure': 'Cmin for Rilotumumab - Part 2', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmin = minimum drug concentration during a dosing interval'}, {'measure': 'Cmax for Rilotumumab - Part 2', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmax = maximum observed drug concentration during a dosing interval'}, {'measure': 'Cmin for Ganitumab - Part 2', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmin = minimum drug concentration during a dosing interval'}, {'measure': 'Cmax for Ganitumab - Part 2', 'timeFrame': 'Up to 23 weeks', 'description': 'Cmax = maximum observed drug concentration during a dosing interval'}, {'measure': 'Total Anti-Panitumumab Antibody Incidence - Part 2', 'timeFrame': 'First dose of any study drug and before 120 days of last dose of study drugs; up to 1 year, eight months', 'description': 'Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by either Biacore or ELISA.'}, {'measure': 'Total Anti-AMG 102 Antibody Incidence - Part 2', 'timeFrame': 'First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.', 'description': 'Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.'}, {'measure': 'Total Anti-AMG 479 Antibody Incidence - Part 2', 'timeFrame': 'First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.', 'description': 'Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.'}, {'measure': 'AUC for Rilotumumab', 'timeFrame': '14 Days', 'description': 'AUC = area under the drug concentration-time curve during a dosing interval'}, {'measure': 'AUC for Panitumumab', 'timeFrame': '14 Days', 'description': 'AUC = area under the drug concentration-time curve during a dosing interval'}]}, 'conditionsModule': {'keywords': ['panitumumab', 'vectibix', 'AMG 102', 'AMG 479', 'colon cancer', 'rectal cancer', 'colorectal cancer', 'metastatic colorectal cancer', 'EGFR inhibitor', 'IGF inhibitor', 'c-MET inhibitor'], 'conditions': ['Colon Cancer', 'Colorectal Cancer', 'Gastrointestinal Cancer', 'Metastatic Colorectal Cancer', 'Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '24919569', 'type': 'BACKGROUND', 'citation': 'Van Cutsem E, Eng C, Nowara E, Swieboda-Sadlej A, Tebbutt NC, Mitchell E, Davidenko I, Stephenson J, Elez E, Prenen H, Deng H, Tang R, McCaffery I, Oliner KS, Chen L, Gansert J, Loh E, Smethurst D, Tabernero J. Randomized phase Ib/II trial of rilotumumab or ganitumab with panitumumab versus panitumumab alone in patients with wild-type KRAS metastatic colorectal cancer. Clin Cancer Res. 2014 Aug 15;20(16):4240-50. doi: 10.1158/1078-0432.CCR-13-2752. Epub 2014 Jun 11.'}, {'pmid': '26049686', 'type': 'DERIVED', 'citation': 'Peeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/24919569/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2 part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus panitumumab alone in patients with metastatic colorectal cancer whose tumors are wild-type KRAS status.', 'detailedDescription': 'This study consisted of 3 parts:\n\nPart 1: determination of the tolerable dose of rilotumumab in combination with panitumumab to be administered in Part 2.\n\nPart 2: Comparison of the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus that of panitumumab alone. In Part 2, participants were randomized 1:1:1 into 3 cohorts: 6 mg/kg panitumumab plus 10 mg/kg rilotumumab, 6 mg/kg panitumumab plus 12 mg/kg ganitumab, or 6 mg/kg panitumumab and placebo (panitumumab alone cohort). Panitumumab was administered open-label, and rilotumumab and ganitumab were double-blinded.\n\nPart 3: Exploratory evaluation of the safety and efficacy of the rilotumumab and ganitumab monotherapy following treatment with panitumumab in Part 2. In Part 3, eligible participants who terminated panitumumab treatment in the Panitumumab Alone arm of Part 2 due to disease progression or intolerability could be randomized 1:1 into 2 double-blind cohorts: 10 mg/kg rilotumumab or 12 mg/kg ganitumab.\n\nParticipants who permanently discontinued all the investigational products completed a safety follow-up visit 30 days and a follow-up visit 60 days after the last dose of investigational product. Participants were followed for radiographic disease progression and survival every 3 months after the 30-day safety follow-up visit for up to 2 years after the last participant was enrolled in Part 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* metastatic adenocarcinoma of the colon or rectum\n* wild-type KRAS tumor status\n* radiographic evidence of disease progression during or following treatment with irinotecan and/or oxaliplatin containing chemotherapy for mCRC\n* measurable disease \\>/= 20 mm per Response Evaluation Criteria In Solid Tumors (RECIST)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* adequate laboratory values\n\nExclusion Criteria:\n\n* history of central nervous system (CNS) metastases\n* history of another primary cancer, unless:\n* curatively resected non-melanomatous skin cancer\n* curatively treated cervical carcinoma in situ\n* other primary solid tumor treated with curative intent and no known active disease present for \\>/= 5 years\n* prior treatment with an anti-epithelial growth factor receptor (EGFR), hepatocyte growth factor receptor (HGFR, c-MET), and/or insulin-like growth factor receptor (IGFR) inhibitor\n* prior treatment with AMG 102 or AMG 479\n* prior treatment with chemotherapy or radiotherapy \\</= 21 days\n* prior treatment with targeted therapy \\</= 30 days\n* known allergy or hypersensitivity to panitumumab, AMG 102, or AMG 479\n* history of interstitial lung disease\n* clinically significant cardiovascular disease \\</= 1 year\n* active inflammatory bowel disease\n* known human immunodeficiency virus (HIV), hepatitis C, or hepatitis B infection\n* any co-morbid disease or condition that could increase the risk of toxicity\n* serious or non-healing wound \\</= 35 days\n* any uncontrolled concurrent illness or history of any medical condition that could interfere with the interpretation of the study results\n* major surgical procedure \\</= 35 days or minor surgical procedure \\</= 14 days\n* other investigational procedures or drugs \\</= 30 days'}, 'identificationModule': {'nctId': 'NCT00788957', 'briefTitle': 'Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'NantBioScience, Inc.'}, 'officialTitle': 'A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination With Panitumumab Versus Panitumumab Alone in Subject With Wild-Type KRAS Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': '20060447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.', 'interventionNames': ['Drug: Panitumumab', 'Drug: Rilotumumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2: Panitumumab Alone', 'description': 'Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.', 'interventionNames': ['Drug: Panitumumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Panitumumab + Rilotumumab', 'description': 'Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.', 'interventionNames': ['Drug: Panitumumab', 'Drug: Rilotumumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Panitumumab + Ganitumab', 'description': 'Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.', 'interventionNames': ['Drug: Panitumumab', 'Drug: Ganitumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: Rilotumumab', 'description': 'Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.', 'interventionNames': ['Drug: Rilotumumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: Ganitumab', 'description': 'Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.', 'interventionNames': ['Drug: Ganitumab', 'Drug: Placebo']}], 'interventions': [{'name': 'Panitumumab', 'type': 'DRUG', 'otherNames': ['Vectibix®'], 'description': 'Panitumumab for intravenous infusion', 'armGroupLabels': ['Part 1: Panitumumab + Rilotumumab', 'Part 2: Panitumumab + Ganitumab', 'Part 2: Panitumumab + Rilotumumab', 'Part 2: Panitumumab Alone']}, {'name': 'Ganitumab', 'type': 'DRUG', 'otherNames': ['AMG 479'], 'description': 'Ganitumab for intravenous infusion', 'armGroupLabels': ['Part 2: Panitumumab + Ganitumab', 'Part 3: Ganitumab']}, {'name': 'Rilotumumab', 'type': 'DRUG', 'otherNames': ['AMG 102'], 'description': 'Rilotumumab for intravenous infusion', 'armGroupLabels': ['Part 1: Panitumumab + Rilotumumab', 'Part 2: Panitumumab + Rilotumumab', 'Part 3: Rilotumumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo intravenous infusion', 'armGroupLabels': ['Part 2: Panitumumab + Ganitumab', 'Part 2: Panitumumab + Rilotumumab', 'Part 3: Ganitumab', 'Part 3: Rilotumumab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NantBioScience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}