Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT01346969
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2011-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Sponsor:
Organization:
Raw JSON
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Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to Week 24', 'eventGroups': [{'id': 'EG000', 'title': 'EXC 001 (PF-06473871) 5 mg/cm', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.', 'otherNumAtRisk': 27, 'otherNumAffected': 13, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EXC 001 (PF-06473871) 2 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.', 'otherNumAtRisk': 14, 'otherNumAffected': 2, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'EXC 001 (PF-06473871) 0.8 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.', 'otherNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'EXC 001 (PF-06473871) 5 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.', 'otherNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lyme disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Breast induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vulvovaginal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physician Observer Scar Assessment Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EXC 001 (PF-06473871) 5 mg/cm', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG001', 'title': 'EXC 001 (PF-06473871) 2 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG002', 'title': 'EXC 001 (PF-06473871) 0.8 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG003', 'title': 'EXC 001 (PF-06473871) 5 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}], 'classes': [{'title': 'Overall Opinion', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.87', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '1.97', 'groupId': 'OG003'}]}]}, {'title': 'Vascularity', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.91', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.52', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '1.64', 'groupId': 'OG003'}]}]}, {'title': 'Pigmentation', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.10', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '1.36', 'groupId': 'OG003'}]}]}, {'title': 'Thickness', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '2.04', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '1.90', 'groupId': 'OG003'}]}]}, {'title': 'Relief', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.95', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '2.36', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '1.90', 'groupId': 'OG003'}]}]}, {'title': 'Pliability', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.27', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.71', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '1.62', 'groupId': 'OG003'}]}]}, {'title': 'Surface Area', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.85', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.90', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '2.15', 'groupId': 'OG003'}]}]}, {'title': 'Composite Score', 'categories': [{'measurements': [{'value': '0.2', 'spread': '10.53', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '12.60', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '9.76', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '8.67', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'groupDescription': 'Overall Opinion: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '1.000', 'groupIds': ['OG000'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.37', 'groupDescription': 'Vascularity: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.391', 'groupIds': ['OG000'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Pigmentation: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.696', 'groupIds': ['OG000'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Thickness: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.921', 'groupIds': ['OG000'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Relief: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.693', 'groupIds': ['OG000'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Pliability: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.770', 'groupIds': ['OG000'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Surface Area: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.938', 'groupIds': ['OG000'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '4.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.98', 'groupDescription': 'Composite Score: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.340', 'groupIds': ['OG001'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'Overall Opinion: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.258', 'groupIds': ['OG001'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'groupDescription': 'Vascularity: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.381', 'groupIds': ['OG001'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'groupDescription': 'Pigmentation: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.287', 'groupIds': ['OG001'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Thickness: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.420', 'groupIds': ['OG001'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': 'Relief: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.227', 'groupIds': ['OG001'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': 'Pliability: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.427', 'groupIds': ['OG001'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Surface Area: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.256', 'groupIds': ['OG001'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '2.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.70', 'groupDescription': 'Composite Score: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.198', 'groupIds': ['OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '2.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'groupDescription': 'Overall Opinion: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.132', 'groupIds': ['OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '2.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.60', 'groupDescription': 'Vascularity: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.227', 'groupIds': ['OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'groupDescription': 'Pigmentation: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.208', 'groupIds': ['OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '2.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'groupDescription': 'Thickness: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.265', 'groupIds': ['OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'groupDescription': 'Relief: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.340', 'groupIds': ['OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'groupDescription': 'Pliability: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.347', 'groupIds': ['OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.64', 'groupDescription': 'Surface Area: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.179', 'groupIds': ['OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '10.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.19', 'groupDescription': 'Composite Score: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.556', 'groupIds': ['OG003'], 'paramType': 'Least Square (LS) Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'groupDescription': 'Overall Opinion: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.760', 'groupIds': ['OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Vascularity: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.636', 'groupIds': ['OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': 'Pigmentation: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.774', 'groupIds': ['OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'groupDescription': 'Thickness: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.771', 'groupIds': ['OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'groupDescription': 'Relief: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.468', 'groupIds': ['OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'groupDescription': 'Pliability: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.886', 'groupIds': ['OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'groupDescription': 'Surface Area: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}, {'pValue': '0.668', 'groupIds': ['OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '4.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.91', 'groupDescription': 'Composite Score: Intraparticipant analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (Overall Number of Participants Analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Physician Observer Scar Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EXC 001 (PF-06473871) 5 mg/cm', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG001', 'title': 'EXC 001 (PF-06473871) 2 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG002', 'title': 'EXC 001 (PF-06473871) 0.8 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG003', 'title': 'EXC 001 (PF-06473871) 5 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}], 'classes': [{'title': 'Week 11, Overall Opinion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.07', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '2.04', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '1.54', 'groupId': 'OG003'}]}]}, {'title': 'Week 11, Vascularity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '1.21', 'groupId': 'OG003'}]}]}, {'title': 'Week 11, Pigmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.78', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.50', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '1.54', 'groupId': 'OG003'}]}]}, {'title': 'Week 11, Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.15', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.99', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '1.85', 'groupId': 'OG003'}]}]}, {'title': 'Week 11, Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '2.28', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '2.26', 'groupId': 'OG003'}]}]}, {'title': 'Week 11, Pliability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.29', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '2.27', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '1.76', 'groupId': 'OG003'}]}]}, {'title': 'Week 11, Surface Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.27', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '1.04', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '1.82', 'groupId': 'OG003'}]}]}, {'title': 'Week 11, Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '11.19', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '9.75', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '8.57', 'groupId': 'OG003'}]}]}, {'title': 'Week 18, Overall Opinion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.43', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '2.05', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '2.25', 'groupId': 'OG003'}]}]}, {'title': 'Week 18, Vascularity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.24', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.97', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '1.57', 'groupId': 'OG003'}]}]}, {'title': 'Week 18, Pigmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '1.56', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '1.79', 'groupId': 'OG003'}]}]}, {'title': 'Week 18, Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.28', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.97', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '2.29', 'groupId': 'OG003'}]}]}, {'title': 'Week 18, Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.49', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.86', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '2.21', 'groupId': 'OG003'}]}]}, {'title': 'Week 18, Pliability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.21', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '2.24', 'groupId': 'OG003'}]}]}, {'title': 'Week 18, Surface Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.75', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '2.40', 'groupId': 'OG003'}]}]}, {'title': 'Week 18, Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '10.45', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '9.45', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '11.21', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 11, 18', 'description': 'Physician observer scar assessment score was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time point for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Expert Panel Scar Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EXC 001 (PF-06473871) 5 mg/cm', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG001', 'title': 'EXC 001 (PF-06473871) 2 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG002', 'title': 'EXC 001 (PF-06473871) 0.8 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG003', 'title': 'EXC 001 (PF-06473871) 5 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}], 'classes': [{'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '14.67', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '15.89', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '13.18', 'groupId': 'OG002'}, {'value': '-4.1', 'spread': '13.71', 'groupId': 'OG003'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '14.70', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '13.54', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '14.28', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '15.94', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '15.94', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '17.78', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '15.38', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '15.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 11, 18, 24', 'description': 'Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the "worse" scar and then rated the other scar. The difference between these two ratings was the "improvement of scar severity." If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time point for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Subject Observer Scar Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EXC 001 (PF-06473871) 5 mg/cm', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG001', 'title': 'EXC 001 (PF-06473871) 2 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG002', 'title': 'EXC 001 (PF-06473871) 0.8 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG003', 'title': 'EXC 001 (PF-06473871) 5 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}], 'classes': [{'title': 'Overall Opinion', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.22', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '2.35', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '2.55', 'groupId': 'OG003'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.51', 'groupId': 'OG003'}]}]}, {'title': 'Itching', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.65', 'groupId': 'OG003'}]}]}, {'title': 'Color', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.82', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '2.05', 'groupId': 'OG003'}]}]}, {'title': 'Stiffness', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.06', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '2.22', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '3.00', 'groupId': 'OG003'}]}]}, {'title': 'Thickness', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '2.41', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '3.19', 'groupId': 'OG003'}]}]}, {'title': 'Irregular', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.96', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '2.58', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '3.05', 'groupId': 'OG003'}]}]}, {'title': 'Composite Score', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '9.03', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '6.80', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '8.52', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '11.34', 'groupId': 'OG003'}]}]}, {'title': 'Scar Appearance Composite Score', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '6.77', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '6.44', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '7.68', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '10.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (Overall Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Physician Photonumeric Guide Scar Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EXC 001 (PF-06473871) 5 mg/cm', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG001', 'title': 'EXC 001 (PF-06473871) 2 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG002', 'title': 'EXC 001 (PF-06473871) 0.8 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG003', 'title': 'EXC 001 (PF-06473871) 5 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}], 'classes': [{'title': '4 times EXC 001, minimal', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '4 times EXC 001, mild', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': '4 times EXC 001, moderate', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '4 times EXC 001, severe', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '4 times EXC 001, very severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '3 times EXC 001/Placebo, minimal', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '3 times EXC 001/Placebo, mild', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '3 times EXC 001/Placebo, moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '3 times EXC 001/Placebo, severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '3 times EXC 001/Placebo, very severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': "Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Participant Photonumeric Guide Scar Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EXC 001 (PF-06473871) 5 mg/cm', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG001', 'title': 'EXC 001 (PF-06473871) 2 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG002', 'title': 'EXC 001 (PF-06473871) 0.8 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'OG003', 'title': 'EXC 001 (PF-06473871) 5 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}], 'classes': [{'title': '4 times EXC 001, minimal', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '4 times EXC 001, mild', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '4 times EXC 001, moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '4 times EXC 001, severe', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '4 times EXC 001, very severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '3 times EXC 001/Placebo, minimal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '3 times EXC 001/Placebo, mild', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '3 times EXC 001/Placebo, moderate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '3 times EXC 001/Placebo, severe', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '3 times EXC 001/Placebo, very severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': "Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EXC 001 (PF-06473871) 5 mg/cm', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'FG001', 'title': 'EXC 001 (PF-06473871) 2 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'FG002', 'title': 'EXC 001 (PF-06473871) 0.8 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'FG003', 'title': 'EXC 001 (PF-06473871) 5 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants who previously had breast surgery resulting in unacceptable bilateral scars and had chosen to have the breast scars revised were recruited in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'EXC 001 (PF-06473871) 5 mg/cm', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'BG001', 'title': 'EXC 001 (PF-06473871) 2 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'BG002', 'title': 'EXC 001 (PF-06473871) 0.8 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'BG003', 'title': 'EXC 001 (PF-06473871) 5 mg/cm and Placebo', 'description': 'Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '43.2', 'spread': '7.16', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '13.29', 'groupId': 'BG002'}, {'value': '38.4', 'spread': '8.22', 'groupId': 'BG003'}, {'value': '39.9', 'spread': '10.13', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population was defined as all participants that have missed no more than 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'dispFirstSubmitDate': '2013-05-30', 'completionDateStruct': {'date': '2012-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-12', 'studyFirstSubmitDate': '2011-05-01', 'dispFirstSubmitQcDate': '2013-05-30', 'resultsFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2011-05-03', 'dispFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-12', 'studyFirstPostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician Observer Scar Assessment Score at Week 24', 'timeFrame': 'Week 24', 'description': 'Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.'}], 'secondaryOutcomes': [{'measure': 'Physician Observer Scar Assessment Score', 'timeFrame': 'Week 11, 18', 'description': 'Physician observer scar assessment score was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.'}, {'measure': 'Expert Panel Scar Assessment Score', 'timeFrame': 'Week 11, 18, 24', 'description': 'Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the "worse" scar and then rated the other scar. The difference between these two ratings was the "improvement of scar severity." If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair.'}, {'measure': 'Subject Observer Scar Assessment Score', 'timeFrame': 'Week 24', 'description': 'Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome.'}, {'measure': 'Number of Participants With Physician Photonumeric Guide Scar Assessment Score', 'timeFrame': 'Week 24', 'description': "Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times)."}, {'measure': 'Number of Participants With Participant Photonumeric Guide Scar Assessment Score', 'timeFrame': 'Week 24', 'description': "Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin scarring', 'cicatrix', 'breast scar'], 'conditions': ['Reduction in Hypertrophic Skin Scarring']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=EXC001-204&StudyName=Safety%20and%20Efficacy%20Study%20of%20EXC%20001%20to%20Improve%20the%20Appearance%20of%20Scars%20From%20Prior%20Breast%20Surgery', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have previous had breast surgery resulting in unacceptable scars.\n* Subject has chosen to have breast scars revised.\n* Subject must not be pregnant or lactating.\n\nExclusion Criteria:\n\n* Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or lactating.\n* Participation in another clinical trial within 30 days prior to the start of the study.\n* Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT01346969', 'briefTitle': 'Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS (LEGACY EXCALIARD PROTOCOL # EXC 001-204)', 'orgStudyIdInfo': {'id': 'EXC 001-204'}, 'secondaryIdInfos': [{'id': 'B5301004', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'interventionNames': ['Drug: EXC 001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'interventionNames': ['Drug: EXC 001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3', 'interventionNames': ['Drug: EXC 001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 4', 'interventionNames': ['Drug: EXC 001']}], 'interventions': [{'name': 'EXC 001', 'type': 'DRUG', 'description': 'Single-dose administered by injection four different times', 'armGroupLabels': ['Group 1']}, {'name': 'EXC 001', 'type': 'DRUG', 'description': 'Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1', 'armGroupLabels': ['Group 2']}, {'name': 'EXC 001', 'type': 'DRUG', 'description': 'Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2', 'armGroupLabels': ['Group 3']}, {'name': 'EXC 001', 'type': 'DRUG', 'description': 'Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Skin Deep Laser Medical Spa', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Bright Health Physicans Plastic Surgery and Aesthetic Medicine', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '33461', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Altus Research', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bayside Ambulatory Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33146', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Aesthetic Plastic Surgery Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Body Aesthetic Plastic Surgery', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07042', 'city': 'Montclair', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Plastic Surgery', 'geoPoint': {'lat': 40.82593, 'lon': -74.20903}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Mark L. Jewell,MD Surgery Center', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97062', 'city': 'Tualatin', 'state': 'Oregon', 'country': 'United States', 'facility': 'Connall Consmetic Surgery', 'geoPoint': {'lat': 45.38401, 'lon': -122.76399}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials,P.A.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240-1670', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Plastic Surgery', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98043', 'city': 'Mountlake Terrace', 'state': 'Washington', 'country': 'United States', 'facility': 'BAXTER Plastic Surgery', 'geoPoint': {'lat': 47.78815, 'lon': -122.30874}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}