Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-04 @ 2:33 PM
Study NCT ID:
NCT00472459
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2007-05-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D001913', 'term': "Bowen's Disease"}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010778', 'term': 'Photochemotherapy'}, {'id': 'C475457', 'term': 'methyl 5-aminolevulinate'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Studies@galderma.com', 'phone': '817 961 5000', 'title': 'Clinical Operations', 'phoneExt': '1', 'organization': 'Galderma'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were reported from the first treatment up to the 27-month follow up period.', 'description': "Safety population that included in the study and received Metvix® cream were included in safety evaluation. Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treatment area. Participants with systemic Adverse Events were not considered at risk for these events in the Treatment area and contralateral control area arms since those arms were limited to the analysis of localized events.", 'eventGroups': [{'id': 'EG000', 'title': 'Metvix®-PDT', 'description': 'Two contralateral areas (symmetrically)were identified with an area of 5\\*10-centimeter square,i.e., treatment and control area. Treatment area was treated with Metvix® PDT 160mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments given were given at Months 3, 9, 15, 21 and 27. Adverse Events localized to the treatment area are reported.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 61, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21and 27. Adverse Events localized to the contralateral Control Area.", 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 39, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'All Study Participants', 'description': 'Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 27, 'seriousNumAtRisk': 81, 'deathsNumAffected': 6, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pain of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Skin Burning Sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Skin Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Actinic Keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Neurodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Angioneurotic Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Leukocytoclastic Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Skin Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Skin Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Stasis Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Swelling Face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'seriousEvents': [{'term': 'Squamous Cell Carcinoma of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Actinic Keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Thyroid Gland cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Gouty Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Rectal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Parathyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Renal Transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Wound Secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Knee Arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Calcus Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Postoperative Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Post Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Neoplasm Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Renal Impairement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Complications of Transplanted Kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Herpes Simplex Ophthalmic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Accumulated New Skin Lesions at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®- PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0120', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.514', 'ciLowerLimit': '0.116', 'ciUpperLimit': '0.911', 'estimateComment': 'The 95 % confidence intervals for the lesion complete response rates and lesion recurrence rates were estimated using the method of Clopper and Pearson.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': "Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type."}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 3', 'description': 'A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of actinic keratoses (AK) lesions, basal cell carcinoma (BCC) lesions, squamous cell carcinoma (SCC) lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 3 were reported.', 'unitOfMeasure': 'new skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "Intent-to-Treat (ITT) Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm."}, {'type': 'PRIMARY', 'title': 'Number of Accumulated New Skin Lesions at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3 ,9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1761', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.413', 'ciLowerLimit': '-0.190', 'ciUpperLimit': '1.016', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': "Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type."}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 9', 'description': 'A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 9 were reported.', 'unitOfMeasure': 'new skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm."}, {'type': 'PRIMARY', 'title': 'Number of Accumulated New Skin Lesions at Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (e.g., cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1183', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.600', 'ciLowerLimit': '-0.156', 'ciUpperLimit': '1.357', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': "Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type."}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 15', 'description': 'A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 15 were reported.', 'unitOfMeasure': 'new skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm."}, {'type': 'PRIMARY', 'title': 'Number of Accumulated New Skin Lesions at Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (e.g., cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2322', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.493', 'ciLowerLimit': '-0.323', 'ciUpperLimit': '1.309', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': "Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type."}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 21', 'description': 'A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 21 were reported.', 'unitOfMeasure': 'new skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm."}, {'type': 'PRIMARY', 'title': 'Number of Accumulated New Skin Lesions at Month 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®- PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (e.g., cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1286', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.680', 'ciLowerLimit': '-0.202', 'ciUpperLimit': '1.562', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': "Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type."}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 27', 'description': 'A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 27 were reported.', 'unitOfMeasure': 'new skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm."}, {'type': 'PRIMARY', 'title': 'Number of AK Lesions That Showed Complete Response at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'categories': [{'measurements': [{'value': '296', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 3', 'description': 'Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.', 'unitOfMeasure': 'skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm."}, {'type': 'PRIMARY', 'title': 'Number of AK Lesions That Showed Complete Response at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 9', 'description': 'Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.', 'unitOfMeasure': 'skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm."}, {'type': 'PRIMARY', 'title': 'Number of AK Lesions That Showed Complete Response at Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'categories': [{'measurements': [{'value': '286', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 15', 'description': 'Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.', 'unitOfMeasure': 'skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm."}, {'type': 'PRIMARY', 'title': 'Number of AK Lesions That Showed Complete Response at Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'categories': [{'measurements': [{'value': '275', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 21', 'description': 'Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.', 'unitOfMeasure': 'skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm."}, {'type': 'PRIMARY', 'title': 'Number of AK Lesions That Showed Complete Response at Month 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 27', 'description': 'Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.', 'unitOfMeasure': 'skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of AK lesions analyzed in each Arm."}, {'type': 'SECONDARY', 'title': 'Number of BCC Lesions That Showed Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Month 15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Month 21', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Month 27', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 3, 9, 15, 21 and 27', 'description': 'Complete response was defined as the complete disappearance of the lesion. BCC lesions were characterized as superficial: ill-defined red scaly macule; could increase in size to form crusted, occasionally ulcerated, scaly erythematous patches, but never indurated and nodular: flesh-colored, cream to pink, waxy papule with prominent surface telangiectasias; as the lesions grow, central erosion or ulceration and crusting occur, surrounded by a pearly, rolled, translucent border. Number of BCC lesions that showed complete response was reported.', 'unitOfMeasure': 'skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT Population included all treated participants. Here, 'Overall Number of Units Analyzed' reflects the total number of BCC lesions analyzed in each Arm."}, {'type': 'SECONDARY', 'title': 'Number of Recurrent Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Placebo-PDT', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Month 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'units': 'skin lesions', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 9, 15, 21 and 27', 'description': 'Recurrence of lesions was defined as reappearance of previously treated and eradicated lesions and was verified by histology in accordance with local hospital practice.', 'unitOfMeasure': 'skin lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin lesions', 'denomUnitsSelected': 'skin lesions', 'populationDescription': "ITT population included all participants who were enrolled and treated at baseline. Here, 'Overall Number of Units Analyzed' reflects the total number of skin lesions analyzed in each Arm."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'classes': [{'title': 'Hyperpigmentation (Assessor- Investigator): None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Hyperpigmentation (Assessor- Investigator): Slight/Obvious', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hyperpigmentation (Assessor- Participant): None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Hyperpigmentation (Assessor- Participant): Slight/Obvious', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypopigmentation (Assessor- Investigator): None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Hypopigmentation (Assessor- Investigator): Slight/Obvious', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Hypopigmentation (Assessor- Participant): None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Hypopigmentation (Assessor- Participant): Slight/Obvious', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Scar formation (Assessor- Investigator): None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Scar formation (Assessor- Investigator): Slight/Obvious', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Scar formation (Assessor- Participant: None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Scar formation (Assessor- Participant): Slight/Obvious', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Tissue defect (Assessor- Investigator): None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Tissue defect (Assessor- Investigator): Slight/Obvious', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Tissue defect (Assessor- Participant): None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Tissue defect (Assessor- Participant): Slight/Obvious', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 27', 'description': 'Overall cosmetic outcome for the two contralateral areas (treatment and contralateral control) with an area of 5 by 10 cm\\^2 was assessed with regards to either absence or presence of all signs or symptoms or the presence of at least one of the signs or symptoms; scarring, atrophy, depigmentation, redness and fibrosis by both investigator and participant. Parameters were assessed for each area were hypopigmentation, hyperpigmentation, scar formation and tissue defect. The occurrence of these parameters was graded as none, slight, or obvious. Cosmetic outcome was presented as number of participants in each category (none, slight, obvious) for each variable assessed (hypopigmentation, hyperpigmentation, scar formation, tissue defect).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-population. Here, "overall number of participants analyzed" signifies number of participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for each specified category.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix®-PDT', 'description': 'Two contralateral areas (symmetrically)were identified with an area of 5\\*10-centimeter square,i.e., treatment and control area. Treatment area was treated with Metvix® PDT 160mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments given were given at Months 3, 9, 15, 21 and 27. Adverse Events localized to the treatment area are reported.'}, {'id': 'OG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21and 27. Adverse Events localized to the contralateral Control Area."}, {'id': 'OG002', 'title': 'Not Applicable', 'description': 'Participants none of the area were assigned to either of treatment. All Adverse Events, including those that affected participants as a whole (systemic events).'}], 'classes': [{'title': 'Participants with AE', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Participants with SAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Month 27', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population that included in the study and received Metvix® cream were included in safety evaluation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metvix®- PDT (Treatment Area)', 'description': 'Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, i.e., treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 mg/g cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27.'}, {'id': 'FG001', 'title': 'Contralateral Control Area', 'description': "The contralateral control area was treated using lesion-specific treatment in accordance with the investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '485', 'numSubjects': '81'}, {'groupId': 'FG001', 'numUnits': '422', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '476', 'numSubjects': '55'}, {'groupId': 'FG001', 'numUnits': '413', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '26'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Heavy workload, Not satisfied, Squamous Cell Carcinoma', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Skin lesions', 'recruitmentDetails': 'This study was conducted at 5 countries (Denmark, Germany, Norway, Sweden, and United Kingdom) between 25 July 2003 to 14 July 2006.', 'preAssignmentDetails': 'A total of 82 participants were randomized in the study, of which 81 participants were treated on one side of the participant (Treatment area) with Metvix®-PDT and other side of the participants (Contralateral Control Area).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': "All participants were transplant recipients who had received immune suppressive therapy for at least 3 years and had skin lesions in each of two symmetrical contralateral areas on the face, scalp, extremities or trunk/neck received Metrvix®-PDT on one side of patient (treatment area) given as fractionated regimen on Week 0, Week 1, 3 months, 9 months and 15 months followed by other side of the patients selected area (Contralateral Control Area) was treated using lesion-specific treatment in accordance with the Investigator's preference."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'spread': '10.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) Population included all treated participants. As per planned analysis unique participants baseline was not analysed, only overall participant data was analysed and reported.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2006-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2007-05-10', 'resultsFirstSubmitDate': '2022-08-08', 'studyFirstSubmitQcDate': '2007-05-10', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-31', 'studyFirstPostDateStruct': {'date': '2007-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2004-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Accumulated New Skin Lesions at Month 3', 'timeFrame': 'At Month 3', 'description': 'A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of actinic keratoses (AK) lesions, basal cell carcinoma (BCC) lesions, squamous cell carcinoma (SCC) lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 3 were reported.'}, {'measure': 'Number of Accumulated New Skin Lesions at Month 9', 'timeFrame': 'At Month 9', 'description': 'A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 9 were reported.'}, {'measure': 'Number of Accumulated New Skin Lesions at Month 15', 'timeFrame': 'At Month 15', 'description': 'A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 15 were reported.'}, {'measure': 'Number of Accumulated New Skin Lesions at Month 21', 'timeFrame': 'At Month 21', 'description': 'A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 21 were reported.'}, {'measure': 'Number of Accumulated New Skin Lesions at Month 27', 'timeFrame': 'At Month 27', 'description': 'A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 27 were reported.'}, {'measure': 'Number of AK Lesions That Showed Complete Response at Month 3', 'timeFrame': 'At Month 3', 'description': 'Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.'}, {'measure': 'Number of AK Lesions That Showed Complete Response at Month 9', 'timeFrame': 'At Month 9', 'description': 'Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.'}, {'measure': 'Number of AK Lesions That Showed Complete Response at Month 15', 'timeFrame': 'At Month 15', 'description': 'Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.'}, {'measure': 'Number of AK Lesions That Showed Complete Response at Month 21', 'timeFrame': 'At Month 21', 'description': 'Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.'}, {'measure': 'Number of AK Lesions That Showed Complete Response at Month 27', 'timeFrame': 'At Month 27', 'description': 'Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.'}], 'secondaryOutcomes': [{'measure': 'Number of BCC Lesions That Showed Complete Response', 'timeFrame': 'At Months 3, 9, 15, 21 and 27', 'description': 'Complete response was defined as the complete disappearance of the lesion. BCC lesions were characterized as superficial: ill-defined red scaly macule; could increase in size to form crusted, occasionally ulcerated, scaly erythematous patches, but never indurated and nodular: flesh-colored, cream to pink, waxy papule with prominent surface telangiectasias; as the lesions grow, central erosion or ulceration and crusting occur, surrounded by a pearly, rolled, translucent border. Number of BCC lesions that showed complete response was reported.'}, {'measure': 'Number of Recurrent Lesions', 'timeFrame': 'At Months 9, 15, 21 and 27', 'description': 'Recurrence of lesions was defined as reappearance of previously treated and eradicated lesions and was verified by histology in accordance with local hospital practice.'}, {'measure': 'Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants', 'timeFrame': 'At Month 27', 'description': 'Overall cosmetic outcome for the two contralateral areas (treatment and contralateral control) with an area of 5 by 10 cm\\^2 was assessed with regards to either absence or presence of all signs or symptoms or the presence of at least one of the signs or symptoms; scarring, atrophy, depigmentation, redness and fibrosis by both investigator and participant. Parameters were assessed for each area were hypopigmentation, hyperpigmentation, scar formation and tissue defect. The occurrence of these parameters was graded as none, slight, or obvious. Cosmetic outcome was presented as number of participants in each category (none, slight, obvious) for each variable assessed (hypopigmentation, hyperpigmentation, scar formation, tissue defect).'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From Baseline up to Month 27', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-melanoma skin cancer', 'Organ transplant recipients', 'Photodynamic therapy', 'Actinic keratosis'], 'conditions': ['Actinic Keratosis', 'Warts', 'Basal Cell Carcinoma', 'Bowens Disease', 'Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Participants on immunosuppressive therapy, e.g., organ recipients, had higher occurrence of AK (Actinic Keratosis) than the untreated population. Keratotic lesions (i.e., AK lesions and warts) in this population were highly associated with development of SCC (Squamous Cell Carcinoma) also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC (Basal Cell Carcinoma), increased with graft survival time and the length of immunosuppressive treatment period.\n\nThe higher risk of developing skin malignancy and more aggressive skin malignancies in this population, indicated the need for early removal of these pre-malignant lesions.\n\nIn this study, two contralateral areas (5x10 cm\\^2) with skin lesions within the participant were compared. One area was received Metvix PDT at defined intervals and the other was received lesion specific treatment at the discretion of the investigator. The primary endpoint was the accumulated number of new lesions during the study and number of AK lesions that showed complete response 3 months after baseline. Secondary endpoints were number of BCC lesions that showed complete response, number of recurrent lesions, assessment of cosmetic outcome and safety.', 'detailedDescription': 'The treatment area (5x10 cm\\^2) was treated at baseline and at 3 ,9 and 15 months visits. At baseline, the area was treated with fractionated Metvix® PDT treatment consisting of two treatment one week apart and at 3 ,9 and 15 months visits with single Metvix® PDT treatment. The participants were evaluated for occurrence of new lesions, lesion response and recurrence at 3 (not recurrence),9,15,21, and 27 months visits. New and recurrent lesions in the treated area were treated with Metvix® PDT treatment. Lesions with partial response in the treated area were re-treated with Metvix® PDT and lesions with no response were treated with lesion specific treatment at the discretion of the investigator.\n\nIn the contralateral control area (5x10 cm\\^2), new and recurrent lesions and lesions in non-complete response were treated with lesion specific treatment at the discretion of the investigator at each study visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Transplant recipients with at least 2 clinically diagnosed AK lesion and maximum 10 skin lesions (AK, BCC, SCC in situ and/or warts) in each of the two contralateral areas (diameter 5x10\\^2 cm) in the face, the scalp, the extremities or on the trunk/neck.\n* Transplant recipients who previously were treated more than once for their skin lesions.\n* Transplant recipients who had received immunosuppressive therapy for more than 3 years.\n* Males or females above 18 years of age.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Participants with more than 10 skin lesions (AK, BCC, SCC in situ, warts) in one of the two areas.\n* Participants with SCC (not SCC in situ) in one of the two areas.\n* Participants not previously treated or treated only once for their skin lesions.\n* Participants with rosacea in one of the two areas.\n* Participants with morphea form/highly infiltrating BCC\n* Known allergy to methyl-amino levulinate, a similar compound or excipients of the cream\n* Participation in other clinical studies either concurrently or within the last 30 days.\n* Pregnant or breast-feeding (all women of child-bearing potential documented a negative pregnancy test and used the pill or IUD during the treatments and for at least one month thereafter).\n* Conditions associated with a risk of poor protocol compliance'}, 'identificationModule': {'nctId': 'NCT00472459', 'briefTitle': 'Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Multicenter, Randomized Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Immuno-compromised Patients With Non-melanoma Skin Cancer', 'orgStudyIdInfo': {'id': 'PC T313/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metvix®-PDT (Treatment Area +Contralateral Control Area)', 'description': "Two contralateral areas (symmetrically) were identified with an area of 5\\*10-centimeter square, that is (i.e.), treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 milligrams/gram (mg/g) cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. The contralateral control area was treated using lesion-specific treatment in accordance with the Investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.", 'interventionNames': ['Procedure: Photodynamic therapy with Metvix 160 mg/g cream']}], 'interventions': [{'name': 'Photodynamic therapy with Metvix 160 mg/g cream', 'type': 'PROCEDURE', 'armGroupLabels': ['Metvix®-PDT (Treatment Area +Contralateral Control Area)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Dermatology, Århus Amysygehus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Department of Dermatology, Roskilde Amysygehus', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klinik für Dermatologie, Venerologie und Allergologie, Campus Charité Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '30449', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hautklinik Linden', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Dermatology, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of Dermatology, St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Department of Dermatology, Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Dermatology, Karolinska University Hospital, Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Department of Dermatology, Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Dermatology Department, Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'PO3 6AD', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': "Portsmouth Dermatology Centre, St Mary's Hospital", 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}], 'overallOfficials': [{'name': 'Ann-Marie Wennberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}