Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT00420056
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2007-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500026', 'term': 'palbociclib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Results are reported for change from baseline in maximum standard uptake value (SUVmax) instead of percent change from baseline in SUVmax.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.", 'otherNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Macrocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Axillary pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Balanitis candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Proctitis monilial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Brachial plexopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Scrotal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Increased upper airway secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation Coefficient Between Change From Baseline in Fluoro-L-thymidine Positron Emission Tomography (FLT-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25034', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.4854', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Cycle 1 Day 21', 'description': "Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram \\[kg\\]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in \\[(18)F\\]-FLT-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.", 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline \\[(18)F\\]-fluorodeoxyglucose PET \\[FDG-PET\\] and \\[(18)F\\]-FLT-PET, and at least 1 on-treatment \\[Day 21\\] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).'}, {'type': 'PRIMARY', 'title': 'Correlation Coefficient Between Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '0.13551', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.7090', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Cycle 1 Day 21', 'description': "Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram \\[kg\\]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in \\[(18)F\\]-FDG-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.", 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline \\[(18)F\\]-FDG-PET and \\[(18)F\\]-FLT-PET, and at least 1 on-treatment \\[Day 21\\] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'title': 'Baseline: FLT-PET', 'categories': [{'measurements': [{'value': '9.964', 'spread': '4.929', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: FDG-PET', 'categories': [{'measurements': [{'value': '9.049', 'spread': '4.654', 'groupId': 'OG000'}]}]}, {'title': 'Change at Cycle 1 Day 21: FLT-PET', 'categories': [{'measurements': [{'value': '-4.551', 'spread': '2.968', 'groupId': 'OG000'}]}]}, {'title': 'Change at Cycle 1 Day 21: FDG-PET', 'categories': [{'measurements': [{'value': '-2.271', 'spread': '2.913', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 21', 'description': 'Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram \\[kg\\]). Change from baseline in SUVmax was assessed using \\[(18)F\\]-FLT-PET and \\[(18)F\\]-FDG-PET techniques.', 'unitOfMeasure': 'standard uptake value (SUV)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging analysis set included participants in FAS who completed baseline \\[(18)F\\]-FDG-PET and \\[(18)F\\]-FLT-PET, and at least 1 on-treatment (Day 21) PET.'}, {'type': 'PRIMARY', 'title': 'Correlation Between Positron Emission Tomography (PET) Response and Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'timeFrame': 'Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for PFS', 'description': 'PET response was defined as complete response (CR) = mean SUVmax same as of background; partial response (PR) = mean SUVmax less than (\\<) 75 percent (%) of baseline; progressive disease (PD) = mean SUVmax greater than (\\>) 125% of baseline; stable disease (SD) = mean SUVmax greater than or equal to (\\>=) 75% of baseline and mean SUVmax less than or equal to (\\<=) 125% of baseline. PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as \\>50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis for this outcome measure was not run as there were so few responders.'}, {'type': 'PRIMARY', 'title': 'Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'title': 'FLT-PET PR, Objective CR', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FLT-PET PR, Objective PR', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'FLT-PET PR, Objective SD', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'FLT-PET PR, Objective PD', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'FLT-PET PR, Indetermined Objective Response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FLT-PET SD, Objective PD', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'FDG-PET PR, Objective PR', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'FDG-PET PR, Objective SD', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'FDG-PET PR, Objective PD', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'FDG-PET SD, Objective CR', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FDG-PET SD, Objective SD', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'FDG-PET SD, Objective PD', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'FDG-PET SD, Objective Indetermined Response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Kappa', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0638', 'ciLowerLimit': '-0.0449', 'ciUpperLimit': '0.1726', 'groupDescription': 'FLT-PET response versus Objective response', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Kappa', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1864', 'ciLowerLimit': '-0.2316', 'ciUpperLimit': '0.6045', 'groupDescription': 'FDG-PET response versus Objective response', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for OR', 'description': 'OR: CR= disappearance of all clinical/radiographic evidence of disease, disease related symptoms and biochemical abnormalities, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeat bone marrow aspiration; PR= dominant nodes decreased by \\>50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions regressed by \\>50% in SPD, no new sites of disease; SD= response \\<PR and no PD, documented \\>=1 time after start of therapy, no new sites of disease; PD= \\>50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease. PET response: CR= mean SUVmax same as background; PR= mean SUVmax \\<75% of baseline; PD= mean SUVmax \\>125% of baseline; SD= mean SUVmax \\>=75% of baseline but \\<=125% of baseline. Correlation was reported as conjoint number of participants with PET response at Cycle 1 Day 21 and OR at end of study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PET response was analyzed using Imaging analysis set and OR was analyzed using response analysis set (all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed).'}, {'type': 'PRIMARY', 'title': 'Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '47.9', 'spread': '25.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.', 'unitOfMeasure': 'percentage of tumor cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '14.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 21', 'description': 'Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.', 'unitOfMeasure': 'percentage of tumor cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Ki-67 Composite Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '191.2', 'spread': '64.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Ki-67 Composite Score at Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '78.5', 'spread': '110.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 21', 'description': 'Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Cyclin D1 Composite Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '165.0', 'spread': '78.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Cyclin D1 Composite Score at Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '124.2', 'spread': '47.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 21', 'description': 'Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose of study medication', 'description': 'Criteria for laboratory test abnormality: Hematology (Hemoglobin \\[\\<0.8\\*lower limit of normal {LLN}\\], Platelets \\[\\<0.5\\*LLN/ \\>1.75\\*upper limit of normal {ULN}\\], White blood cells \\[\\<0.6\\*LLN/ \\>1.5\\*ULN\\], Lymphocytes, Neutrophils \\[\\<0.8\\*LLN/ \\>1.2\\*ULN\\], Basophils, Eosinophils, Monocytes \\[\\>1.2\\*ULN\\]); Liver Function (Total bilirubin \\[\\>1.5\\*ULN\\], Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Alkaline phosphatase \\[\\>0.3\\*ULN\\], Total protein, Albumin \\[\\<0.8\\*LLN/ \\>1.2\\*ULN\\]); Renal Function (Blood urea nitrogen, Creatinine \\[\\>1.3\\*ULN\\], Uric acid \\[\\>1.2\\*ULN\\]); Electrolytes (sodium \\[\\<0.95\\*LLN/ \\>1.05\\*ULN\\], potassium, chloride, calcium, magnesium \\[\\<0.9\\*LLN/ \\>1.1\\*ULN\\], phosphate \\[\\<0.8\\*LLN/ \\>1.2\\*ULN\\]); Other (Glucose \\[\\<0.6\\*LLN/ \\>1.5\\*ULN\\]).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 28 days after last dose of study medication', 'description': 'AE = any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. Severity was assessed as: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe) = unacceptable or intolerable events, significantly interrupting usual daily activity, and requiring systemic medication therapy/other treatment; Grade 4 (Life-threatening) = events causing participant to be in imminent danger of death; Grade 5 (Death) = death related to an AE. Treatment-emergent events = between first dose of study medication and up to 28 days after last dose, that were absent before treatment or that worsened relative to pre-treatment state. A participant may be represented in more than 1 category.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 28 days after last dose of study medication', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The events which were considered treatment-related by sponsor and/or investigator were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '18.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)', 'description': 'PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as \\>50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease. PFS= (first event date minus the first dose date plus 1) divided by 30.44.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '45.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)', 'description': 'OR is defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR). Confirmed responses are those that persist on repeat imaging study 4 weeks after initial documentation of response. Complete response (CR)= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration; Partial response (PR)= dominant nodes decreased by \\>50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by \\>50% in SPD, no new sites of disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'timeFrame': 'Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)', 'description': 'Time in months from first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to objective tumor progression (PD) or death due to any cause. DR= (date of first documentation of PD or death, minus the date of first CR or PR plus 1) divided by 30.44. CR= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before start of therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration. PR= dominant nodes decreased by \\>50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by \\>50% in SPD, no new sites of disease. PD= \\>50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease.', 'reportingStatus': 'POSTED', 'populationDescription': 'For duration of response, the number of participants experiencing objective response was less than 50%, and therefore, it was not feasible to calculate duration of response using Kaplan-Meier method. Hence, no participant was analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Tumor Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '18.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)', 'description': 'Time in months from date of first dose of study medication to first documentation of objective tumor progression (PD). TTP= (last known progression-free date minus date of first dose of study medication plus 1) divided by 30.44. PD was defined as greater than 50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.'}, {'type': 'SECONDARY', 'title': 'Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'classes': [{'title': 'Concentration versus Ki-67 (n=6)', 'categories': [{'measurements': [{'value': '0.27677', 'groupId': 'OG000'}]}]}, {'title': 'Concentration versus Cyclin D1 (n= 6)', 'categories': [{'measurements': [{'value': '-0.69081', 'groupId': 'OG000'}]}]}, {'title': 'Concentration versus phospho-Rb (n= 10)', 'categories': [{'measurements': [{'value': '-0.55533', 'groupId': 'OG000'}]}]}, {'title': 'Concentration versus FLT-PET SUVmax (n= 16)', 'categories': [{'measurements': [{'value': '0.28767', 'groupId': 'OG000'}]}]}, {'title': 'Concentration versus FDG-PET SUVmax (n= 16)', 'categories': [{'measurements': [{'value': '-0.18526', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.5954', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Concentration versus Ki-67', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1286', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Concentration versus Cyclin D1', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0956', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Concentration versus phospho-Rb', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2800', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Concentration versus FLT-PET SUVmax', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4921', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Concentration versus FDG-PET SUVmax', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Cycle 1 Day 21', 'description': "Plasma PD 0332991 concentration at Cycle 1 Day 21 was analyzed. Change from baseline in biomarkers (Ki-67 composite score, Cyclin D1 composite score, phospho-Rb positive cells) and SUVmax (FLT-PET SUVmax, FDG-PET SUVmax) at Cycle 1 Day 21 were analyzed. Correlation between PD 0332991 concentration and change in biomarkers (concentration versus Ki-67, concentration versus Cyclin, and concentration versus phospho-Rb) and SUVmax (concentration versus FLT-PET SUVmax, concentration versus FDG-PET SUVmax) was then assessed. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.", 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'PD 0332991 concentration was analyzed using pharmacokinetic analysis set (participants in FAS who had also completed pharmacokinetic blood sampling for at least 1 day); SUVmax and biomarkers were analyzed using imaging analysis set and tumor analysis set respectively. n= participants evaluable for this measure for specified comparisons.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Objective progression or relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PD 0332991', 'description': "PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '9.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all participants enrolled in the study who received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2007-01-05', 'resultsFirstSubmitDate': '2015-03-04', 'studyFirstSubmitQcDate': '2007-01-05', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-25', 'studyFirstPostDateStruct': {'date': '2007-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Coefficient Between Change From Baseline in Fluoro-L-thymidine Positron Emission Tomography (FLT-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21', 'timeFrame': 'Baseline, Cycle 1 Day 21', 'description': "Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram \\[kg\\]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in \\[(18)F\\]-FLT-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'measure': 'Correlation Coefficient Between Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21', 'timeFrame': 'Baseline, Cycle 1 Day 21', 'description': "Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram \\[kg\\]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in \\[(18)F\\]-FDG-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'measure': 'Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21', 'timeFrame': 'Baseline, Cycle 1 Day 21', 'description': 'Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram \\[kg\\]). Change from baseline in SUVmax was assessed using \\[(18)F\\]-FLT-PET and \\[(18)F\\]-FDG-PET techniques.'}, {'measure': 'Correlation Between Positron Emission Tomography (PET) Response and Progression-Free Survival (PFS)', 'timeFrame': 'Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for PFS', 'description': 'PET response was defined as complete response (CR) = mean SUVmax same as of background; partial response (PR) = mean SUVmax less than (\\<) 75 percent (%) of baseline; progressive disease (PD) = mean SUVmax greater than (\\>) 125% of baseline; stable disease (SD) = mean SUVmax greater than or equal to (\\>=) 75% of baseline and mean SUVmax less than or equal to (\\<=) 125% of baseline. PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as \\>50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.'}, {'measure': 'Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)', 'timeFrame': 'Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for OR', 'description': 'OR: CR= disappearance of all clinical/radiographic evidence of disease, disease related symptoms and biochemical abnormalities, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeat bone marrow aspiration; PR= dominant nodes decreased by \\>50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions regressed by \\>50% in SPD, no new sites of disease; SD= response \\<PR and no PD, documented \\>=1 time after start of therapy, no new sites of disease; PD= \\>50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease. PET response: CR= mean SUVmax same as background; PR= mean SUVmax \\<75% of baseline; PD= mean SUVmax \\>125% of baseline; SD= mean SUVmax \\>=75% of baseline but \\<=125% of baseline. Correlation was reported as conjoint number of participants with PET response at Cycle 1 Day 21 and OR at end of study.'}, {'measure': 'Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Baseline', 'timeFrame': 'Baseline', 'description': 'Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.'}, {'measure': 'Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21', 'timeFrame': 'Cycle 1 Day 21', 'description': 'Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.'}, {'measure': 'Ki-67 Composite Score at Baseline', 'timeFrame': 'Baseline', 'description': 'Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).'}, {'measure': 'Ki-67 Composite Score at Cycle 1 Day 21', 'timeFrame': 'Cycle 1 Day 21', 'description': 'Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).'}, {'measure': 'Cyclin D1 Composite Score at Baseline', 'timeFrame': 'Baseline', 'description': 'Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).'}, {'measure': 'Cyclin D1 Composite Score at Cycle 1 Day 21', 'timeFrame': 'Cycle 1 Day 21', 'description': 'Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'Baseline up to 28 days after last dose of study medication', 'description': 'Criteria for laboratory test abnormality: Hematology (Hemoglobin \\[\\<0.8\\*lower limit of normal {LLN}\\], Platelets \\[\\<0.5\\*LLN/ \\>1.75\\*upper limit of normal {ULN}\\], White blood cells \\[\\<0.6\\*LLN/ \\>1.5\\*ULN\\], Lymphocytes, Neutrophils \\[\\<0.8\\*LLN/ \\>1.2\\*ULN\\], Basophils, Eosinophils, Monocytes \\[\\>1.2\\*ULN\\]); Liver Function (Total bilirubin \\[\\>1.5\\*ULN\\], Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Alkaline phosphatase \\[\\>0.3\\*ULN\\], Total protein, Albumin \\[\\<0.8\\*LLN/ \\>1.2\\*ULN\\]); Renal Function (Blood urea nitrogen, Creatinine \\[\\>1.3\\*ULN\\], Uric acid \\[\\>1.2\\*ULN\\]); Electrolytes (sodium \\[\\<0.95\\*LLN/ \\>1.05\\*ULN\\], potassium, chloride, calcium, magnesium \\[\\<0.9\\*LLN/ \\>1.1\\*ULN\\], phosphate \\[\\<0.8\\*LLN/ \\>1.2\\*ULN\\]); Other (Glucose \\[\\<0.6\\*LLN/ \\>1.5\\*ULN\\]).'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events by Severity', 'timeFrame': 'Day 1 up to 28 days after last dose of study medication', 'description': 'AE = any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. Severity was assessed as: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe) = unacceptable or intolerable events, significantly interrupting usual daily activity, and requiring systemic medication therapy/other treatment; Grade 4 (Life-threatening) = events causing participant to be in imminent danger of death; Grade 5 (Death) = death related to an AE. Treatment-emergent events = between first dose of study medication and up to 28 days after last dose, that were absent before treatment or that worsened relative to pre-treatment state. A participant may be represented in more than 1 category.'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to 28 days after last dose of study medication', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The events which were considered treatment-related by sponsor and/or investigator were reported.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)', 'description': 'PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as \\>50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease. PFS= (first event date minus the first dose date plus 1) divided by 30.44.'}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)', 'description': 'OR is defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR). Confirmed responses are those that persist on repeat imaging study 4 weeks after initial documentation of response. Complete response (CR)= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration; Partial response (PR)= dominant nodes decreased by \\>50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by \\>50% in SPD, no new sites of disease.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)', 'description': 'Time in months from first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to objective tumor progression (PD) or death due to any cause. DR= (date of first documentation of PD or death, minus the date of first CR or PR plus 1) divided by 30.44. CR= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before start of therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration. PR= dominant nodes decreased by \\>50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by \\>50% in SPD, no new sites of disease. PD= \\>50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease.'}, {'measure': 'Time to Tumor Progression (TTP)', 'timeFrame': 'Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)', 'description': 'Time in months from date of first dose of study medication to first documentation of objective tumor progression (PD). TTP= (last known progression-free date minus date of first dose of study medication plus 1) divided by 30.44. PD was defined as greater than 50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.'}, {'measure': 'Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21', 'timeFrame': 'Baseline, Cycle 1 Day 21', 'description': "Plasma PD 0332991 concentration at Cycle 1 Day 21 was analyzed. Change from baseline in biomarkers (Ki-67 composite score, Cyclin D1 composite score, phospho-Rb positive cells) and SUVmax (FLT-PET SUVmax, FDG-PET SUVmax) at Cycle 1 Day 21 were analyzed. Correlation between PD 0332991 concentration and change in biomarkers (concentration versus Ki-67, concentration versus Cyclin, and concentration versus phospho-Rb) and SUVmax (concentration versus FLT-PET SUVmax, concentration versus FDG-PET SUVmax) was then assessed. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lymphoma, Mantle-Cell']}, 'referencesModule': {'references': [{'pmid': '22383795', 'type': 'DERIVED', 'citation': 'Leonard JP, LaCasce AS, Smith MR, Noy A, Chirieac LR, Rodig SJ, Yu JQ, Vallabhajosula S, Schoder H, English P, Neuberg DS, Martin P, Millenson MM, Ely SA, Courtney R, Shaik N, Wilner KD, Randolph S, Van den Abbeele AD, Chen-Kiang SY, Yap JT, Shapiro GI. Selective CDK4/6 inhibition with tumor responses by PD0332991 in patients with mantle cell lymphoma. Blood. 2012 May 17;119(20):4597-607. doi: 10.1182/blood-2011-10-388298. Epub 2012 Mar 1.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5481002', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients with mantle cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically documented MCL.\n* Must have received at least one prior therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Adequate organ function as outlined in the protocol.\n\nExclusion Criteria:\n\n* Major surgery, radiation therapy, or systemic therapy within 4 weeks of study enrollment.\n* Prior radiation therapy to \\>25% of the bone marrow (whole pelvis is 25%).\n* Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.'}, 'identificationModule': {'nctId': 'NCT00420056', 'briefTitle': 'An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Pilot Study Of Pd 0332991 In Patients With Previously Treated Mantle Cell Lymphoma', 'orgStudyIdInfo': {'id': 'A5481002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD-0332991', 'interventionNames': ['Drug: PD-0332991']}], 'interventions': [{'name': 'PD-0332991', 'type': 'DRUG', 'description': '125 mg, oral, Days 1-21 of a 28-day cycle', 'armGroupLabels': ['PD-0332991']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College of Cornell University - New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}