Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-29 @ 12:06 AM
Study NCT ID:
NCT01254292
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2010-11-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C534342', 'term': 'drospirenone and ethinyl estradiol combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'title': 'Therapeutic Area Head', 'organization': 'Bayer AG'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of treatment until 36 months/EOS visit.', 'eventGroups': [{'id': 'EG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months', 'otherNumAtRisk': 279, 'otherNumAffected': 215, 'seriousNumAtRisk': 279, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles', 'otherNumAtRisk': 281, 'otherNumAffected': 148, 'seriousNumAtRisk': 281, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vulvitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vulvovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vulvovaginitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Smear cervix abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Human papilloma virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 16}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 26}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Coital bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Wisdom teeth removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Bacterial vaginosis', 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'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nose deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': "Basedow's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Femoral hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nose deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Borderline ovarian tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Breast fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Breast prosthesis implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Myomectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Mammoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}, {'value': '81.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'single proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '82.1', 'ciLowerLimit': '77.1', 'ciUpperLimit': '86.5', 'estimateComment': 'Clopper Pearson Confidence Interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001'], 'paramType': 'single proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '81.9', 'ciLowerLimit': '76.7', 'ciUpperLimit': '86.4', 'estimateComment': 'Clopper Pearson Confidence Interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with at least one assessment of the overall satisfaction rating)'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Rating by the 5-point Likert Item at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000'}, {'value': '48.1', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}, {'value': '35.8', 'groupId': 'OG001'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months)'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Rating by the 5-point Likert Item at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000'}, {'value': '45.0', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Rating by the 5-point Likert Item at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}, {'value': '52.5', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000'}, {'value': '37.8', 'groupId': 'OG001'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months)'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000'}, {'value': '46.6', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '35.1', 'groupId': 'OG001'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months/EOS', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.\n\nThe 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months/end of study)'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Rate at 6 Months (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months or before)'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Rate at 12 Months (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)'}, {'type': 'SECONDARY', 'title': 'User Satisfaction - Acceptability of the Administration of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Acc. without inconvenience/discomfort', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}]}, {'title': 'Acc. with some inconv/discomfort', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Not acc. with moderate inconv./discomf.', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Not acc. with extreme inconv./discomf', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)'}, {'type': 'SECONDARY', 'title': 'User Satisfaction - Choices Upon Completion of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Continue with study treatment', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': 'Use a different hormonal contraceptive', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Use a different contraceptive method', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Discont. use of all types of contracept.', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'No need for contraceptive at this time', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Undecided', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)'}, {'type': 'SECONDARY', 'title': 'User Satisfaction - Amount of Menstrual Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Decreased', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Not Changed', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}]}, {'title': 'Increased', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)'}, {'type': 'SECONDARY', 'title': 'User Satisfaction - Satisfaction With Menstrual Bleeding Pattern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat satisfied', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Not applicable', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)'}, {'type': 'SECONDARY', 'title': 'User Satisfaction - Frequency of Experiencing Unexpected Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}]}, {'title': 'Seldom', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Often', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Very Often', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)'}, {'type': 'SECONDARY', 'title': 'User Satisfaction - Satisfaction With Menstrual Bleeding Absence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat satisfied', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)'}, {'type': 'SECONDARY', 'title': 'User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Decreased', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Not changed', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}]}, {'title': 'Increased', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)'}, {'type': 'SECONDARY', 'title': 'User Satisfaction - Rating of Usual Menstrual Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)'}, {'type': 'SECONDARY', 'title': 'EVAPIL-R Scores at Screening - Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9386', 'spread': '0.8036', 'groupId': 'OG000'}, {'value': '0.8846', 'spread': '0.8231', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At screening', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the composite score could be calculated)'}, {'type': 'SECONDARY', 'title': 'EVAPIL-R Scores at Screening - Bother Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5569', 'spread': '0.4451', 'groupId': 'OG000'}, {'value': '0.5188', 'spread': '0.4406', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At screening', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the bother score could be calculated)'}, {'type': 'SECONDARY', 'title': 'EVAPIL-R Scores at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Composite score', 'categories': [{'measurements': [{'value': '1.3187', 'spread': '0.9888', 'groupId': 'OG000'}, {'value': '1.1537', 'spread': '0.9947', 'groupId': 'OG001'}]}]}, {'title': 'Bother score', 'categories': [{'measurements': [{'value': '0.7364', 'spread': '0.4940', 'groupId': 'OG000'}, {'value': '0.6550', 'spread': '0.5148', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 6 months', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 6 months where the scores could be calculated)'}, {'type': 'SECONDARY', 'title': 'EVAPIL-R Scores at 12 Months - Bother Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7789', 'spread': '0.5120', 'groupId': 'OG000'}, {'value': '0.6015', 'spread': '0.4663', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 12 months', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the bother score could be calculated)'}, {'type': 'SECONDARY', 'title': 'EVAPIL-R Scores at 12 Months - Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4022', 'spread': '1.0126', 'groupId': 'OG000'}, {'value': '1.0535', 'spread': '0.8698', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 12 months', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the composite score could be calculated)'}, {'type': 'SECONDARY', 'title': 'EVAPIL-R Scores at 18 Months/EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Composite score', 'categories': [{'measurements': [{'value': '1.4804', 'spread': '1.1926', 'groupId': 'OG000'}, {'value': '1.0246', 'spread': '0.9546', 'groupId': 'OG001'}]}]}, {'title': 'Bother score', 'categories': [{'measurements': [{'value': '0.8113', 'spread': '0.5765', 'groupId': 'OG000'}, {'value': '0.5908', 'spread': '0.4836', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 18 months/EOS', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 18 months/end of study where the scores could be calculated)'}, {'type': 'SECONDARY', 'title': 'Cumulative Drop-out Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Up to 6 months', 'categories': [{'measurements': [{'value': '7.53', 'groupId': 'OG000'}, {'value': '11.39', 'groupId': 'OG001'}]}]}, {'title': 'Up to 12 months', 'categories': [{'measurements': [{'value': '13.26', 'groupId': 'OG000'}, {'value': '21.71', 'groupId': 'OG001'}]}]}, {'title': 'Up to 18 months', 'categories': [{'measurements': [{'value': '18.64', 'groupId': 'OG000'}, {'value': '27.40', 'groupId': 'OG001'}]}]}, {'title': 'Up to 24 months', 'categories': [{'measurements': [{'value': '30.85', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Extension phase was only for LCS12 group', 'groupId': 'OG001'}]}]}, {'title': 'Up to 36 months', 'categories': [{'measurements': [{'value': '33.34', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Extension phase was only for LCS12 group', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6, 12, 18, 24 and 36 months', 'description': 'The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated: • LCS12 expulsions • Bleeding pattern alterations • Bleeding pattern alterations with increased bleeding (amount) • Bleeding pattern alterations with decreased bleeding (amount) • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Pearl Index (PI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Pearl index up to 18 months', 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '2.05'}, {'value': '1.82', 'groupId': 'OG001', 'lowerLimit': '0.67', 'upperLimit': '3.97'}]}]}, {'title': 'Pearl index up to 24 months', 'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '1.95'}, {'value': 'NA', 'comment': 'Extension phase was only for LCS12 group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Pearl index up to 36 months', 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '1.67'}, {'value': 'NA', 'comment': 'Extension phase was only for LCS12 group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 18, 24, 36 months', 'description': 'The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.', 'unitOfMeasure': 'Pregnancies per 100 women years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Compliance Rate for Yasmin Pill Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Compliance <=75%', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Compliance >75%', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cumulative Number of Participants With Partial or Total Expulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}], 'classes': [{'title': 'Partial expulsion up to 18 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total expulsion up to 18 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial expulsion up to 24 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Total expulsion up to 24 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial expulsion up to 36 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Total expulsion up to 36 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18, 24, 36 months', 'description': 'Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Investigator's Evaluation of Successful IUS Insertion Procedure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}], 'classes': [{'title': 'Easy', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}]}]}, {'title': 'Slightly difficult', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Very difficult', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Participants' Evaluation of Pain During Successful IUS Insertion Procedure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Investigator's Evaluation of IUS Removal Procedure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}], 'classes': [{'title': 'Easy', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}]}]}, {'title': 'Slightly difficult', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Very difficult', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Participants' Evaluation of Pain During IUS Removal Procedure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)'}, {'type': 'SECONDARY', 'title': 'User Satisfaction - Acceptability of the Administration of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Acc. without inconvenience/discomfort', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}]}, {'title': 'Acc. with some inconv/discomfort', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Not acc. with moderate inconv./discomf.', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Not acc. with extreme inconv./discomf.', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months', 'description': 'The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 6 months)'}, {'type': 'SECONDARY', 'title': 'User Satisfaction - Acceptability of the Administration of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'OG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'classes': [{'title': 'Acc. without inconvenience/discomfort', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}, {'title': 'Acc. with some inconv/discomfort', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Not acc. with moderate inconv./discomf.', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Not acc. with extreme inconv./discomf.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 months', 'description': 'The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 12 months)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'FG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}], 'periods': [{'title': 'Comparative Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '285'}]}, {'type': 'Participants Received Treatment', 'achievements': [{'comment': 'safety population', 'groupId': 'FG000', 'numSubjects': '279'}, {'comment': 'safety population', 'groupId': 'FG001', 'numSubjects': '281'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '204'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '81'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Wish for pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'LCS12 Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'A total of 200 participants elected to enter this optional Extension Phase.', 'groupId': 'FG000', 'numSubjects': '200'}, {'comment': 'Optional Extension Phase was for LCS12 group only.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Wish for pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted in 42 centers across 4 countries in Austria, Belgium, Germany and United States.', 'preAssignmentDetails': '644 subjects were screened, of which 77 were screen failures and 567 were randomized, 282 subjects to LCS12 and 285 subjects to Yasmin. 279 subjects randomized to LCS12 while 281 subjects randomized to Yasmin received treatment and started comparative phase up to 18 months. 200 subjects randomized to LCS12 entered extension phase up to 36 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '560', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months'}, {'id': 'BG001', 'title': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '23.9', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '23.8', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '279', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '560', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of births', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 567}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-24', 'studyFirstSubmitDate': '2010-11-22', 'resultsFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2010-12-03', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-03-31', 'studyFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cumulative Number of Participants With Partial or Total Expulsion', 'timeFrame': 'Up to 18, 24, 36 months', 'description': 'Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.'}, {'measure': "Investigator's Evaluation of Successful IUS Insertion Procedure", 'timeFrame': 'Up to 18 months'}, {'measure': "Participants' Evaluation of Pain During Successful IUS Insertion Procedure", 'timeFrame': 'Up to 18 months'}, {'measure': "Investigator's Evaluation of IUS Removal Procedure", 'timeFrame': 'Up to 36 months'}, {'measure': "Participants' Evaluation of Pain During IUS Removal Procedure", 'timeFrame': 'Up to 36 months'}], 'primaryOutcomes': [{'measure': 'Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)', 'timeFrame': 'At 18 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.'}], 'secondaryOutcomes': [{'measure': 'Overall Satisfaction Rating by the 5-point Likert Item at 6 Months', 'timeFrame': 'At 6 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.'}, {'measure': 'Overall Satisfaction Rating by the 5-point Likert Item at 12 Months', 'timeFrame': 'At 12 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.'}, {'measure': 'Overall Satisfaction Rating by the 5-point Likert Item at 18 Months', 'timeFrame': 'At 18 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.'}, {'measure': 'Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)', 'timeFrame': 'At 18 months/EOS', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.\n\nThe 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.'}, {'measure': 'Overall Satisfaction Rate at 6 Months (LOCF)', 'timeFrame': 'At 6 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.'}, {'measure': 'Overall Satisfaction Rate at 12 Months (LOCF)', 'timeFrame': 'At 12 months', 'description': 'Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.'}, {'measure': 'User Satisfaction - Acceptability of the Administration of Study Treatment', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.'}, {'measure': 'User Satisfaction - Choices Upon Completion of the Study', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.'}, {'measure': 'User Satisfaction - Amount of Menstrual Bleeding', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.'}, {'measure': 'User Satisfaction - Satisfaction With Menstrual Bleeding Pattern', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.'}, {'measure': 'User Satisfaction - Frequency of Experiencing Unexpected Bleeding', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.'}, {'measure': 'User Satisfaction - Satisfaction With Menstrual Bleeding Absence', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.'}, {'measure': 'User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.'}, {'measure': 'User Satisfaction - Rating of Usual Menstrual Pain Intensity', 'timeFrame': 'At 18 months/EOS', 'description': 'The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.'}, {'measure': 'EVAPIL-R Scores at Screening - Composite Score', 'timeFrame': 'At screening', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.'}, {'measure': 'EVAPIL-R Scores at Screening - Bother Score', 'timeFrame': 'At screening', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.'}, {'measure': 'EVAPIL-R Scores at 6 Months', 'timeFrame': 'At 6 months', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.'}, {'measure': 'EVAPIL-R Scores at 12 Months - Bother Score', 'timeFrame': 'At 12 months', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.'}, {'measure': 'EVAPIL-R Scores at 12 Months - Composite Score', 'timeFrame': 'At 12 months', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.'}, {'measure': 'EVAPIL-R Scores at 18 Months/EOS', 'timeFrame': 'At 18 months/EOS', 'description': 'The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.'}, {'measure': 'Cumulative Drop-out Rate', 'timeFrame': 'Up to 6, 12, 18, 24 and 36 months', 'description': 'The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated: • LCS12 expulsions • Bleeding pattern alterations • Bleeding pattern alterations with increased bleeding (amount) • Bleeding pattern alterations with decreased bleeding (amount) • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.'}, {'measure': 'Pearl Index (PI)', 'timeFrame': 'Up to 18, 24, 36 months', 'description': 'The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.'}, {'measure': 'Compliance Rate for Yasmin Pill Intake', 'timeFrame': 'Up to 18 months'}, {'measure': 'User Satisfaction - Acceptability of the Administration of Study Treatment', 'timeFrame': 'At 6 months', 'description': 'The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.'}, {'measure': 'User Satisfaction - Acceptability of the Administration of Study Treatment', 'timeFrame': 'At 12 months', 'description': 'The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional, extension phase. Safety data only will be collected during the extension phase of the study.\n\nSecondary objectives are to observe the tolerability, discontinuation rates, adverse event profiles, occurrences of unintended pregnancies (including calculation of Pearl Index \\[PI\\]), and bleeding profiles with the two birth-control methods. Additionally, data on missed tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of subjects) will be collected. Finally, in the COC group, information will be collected on the psychosocial impact of missed or delayed pill intake.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has signed and dated the Informed Consent Form (ICF).\n* The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening.\n* In the opinion of the investigator, the subject is\n\n * in good health;\n * without uterine conditions that would preempt insertion of LCS12;\n * without conditions/history that would contraindicate the use of oral contraceptives.\n* Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV.\n* As determined by subject's history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days).\n* Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.\n\nExclusion Criteria:\n\n* Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Note: Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum.\n* Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1)\n* Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin.\n* Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding\n* Any genital infection (until successfully treated)\n* Abnormal cervical smear result (see inclusion criteria)\n* Acute, current or history of recurrent pelvic inflammatory disease\n* Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12."}, 'identificationModule': {'nctId': 'NCT01254292', 'briefTitle': 'LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multicenter, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 12 µg LNG/Day Initial in Vitro Release Rate (LCS12) in Comparison to a Combined Oral Contraceptive Containing 30 µg Ethinyl Estradiol and 3 mg Drospirenone (Yasmin®) in Young Women (18-29 Years) Over 18 Months of Use', 'orgStudyIdInfo': {'id': '13362'}, 'secondaryIdInfos': [{'id': '2010-020181-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LCS12 (Skyla, BAY86-5028)', 'description': 'Participants received LCS12 (low dose levonorgestrel \\[LNG\\] intrauterine delivery system \\[IUS\\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months', 'interventionNames': ['Drug: Levonorgestrel IUD (LCS, BAY86-5028)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EE30/DRSP (Yasmin, BAY86-5131)', 'description': 'Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles', 'interventionNames': ['Drug: Yasmin (EE30/DRSP, BAY86-5131)']}], 'interventions': [{'name': 'Levonorgestrel IUD (LCS, BAY86-5028)', 'type': 'DRUG', 'description': 'LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 18 months with optional extension to 36 months for subjects in this group only.', 'armGroupLabels': ['LCS12 (Skyla, BAY86-5028)']}, {'name': 'Yasmin (EE30/DRSP, BAY86-5131)', 'type': 'DRUG', 'description': 'Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one pill / day without any breaks for the entire study duration of 18 months.', 'armGroupLabels': ['EE30/DRSP (Yasmin, BAY86-5131)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Visions Clinical Research - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Grossmont Center for Clinical Research', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Genesis Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33472-2952', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33472-2952', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': "Women's Clinic of Lincoln, PC", 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Columbus Center for Women's Health Research", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239-3011', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239-3011', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research of Philadelphia, LLC', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78414', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Research Associates', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '78414', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Women's: Health, Research, Gynecology", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '3100', 'city': 'Sankt Pölten', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'Ordination Dr. Schmidl-Amann', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '3100', 'city': 'Sankt Pölten', 'state': 'Lower Austria', 'country': 'Austria', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '2700', 'city': 'Wiener Neustadt', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'Dr. Max Stiglbauer', 'geoPoint': {'lat': 47.80485, 'lon': 16.23196}}, {'zip': '2700', 'city': 'Wiener Neustadt', 'state': 'Lower Austria', 'country': 'Austria', 'geoPoint': {'lat': 47.80485, 'lon': 16.23196}}, {'zip': '8570', 'city': 'Voitsberg', 'state': 'Styria', 'country': 'Austria', 'facility': 'Ordination Dr. Trost', 'geoPoint': {'lat': 47.04445, 'lon': 15.15313}}, {'zip': '8570', 'city': 'Voitsberg', 'state': 'Styria', 'country': 'Austria', 'geoPoint': {'lat': 47.04445, 'lon': 15.15313}}, {'zip': '6900', 'city': 'Bregenz', 'state': 'Vorarlberg', 'country': 'Austria', 'facility': 'Landeskrankenhaus Bregenz', 'geoPoint': {'lat': 47.50311, 'lon': 9.7471}}, {'zip': '6900', 'city': 'Bregenz', 'state': 'Vorarlberg', 'country': 'Austria', 'geoPoint': {'lat': 47.50311, 'lon': 9.7471}}, {'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'Praxis Dr. Hannes Kahr', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '9020', 'city': 'Klagenfurt', 'country': 'Austria', 'facility': 'Dr. Bernhard Svejda', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': '9020', 'city': 'Klagenfurt', 'country': 'Austria', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': '3430', 'city': 'Tulln', 'country': 'Austria', 'facility': 'Ordination Dr. Sator', 'geoPoint': {'lat': 48.32829, 'lon': 16.05858}}, {'zip': '3430', 'city': 'Tulln', 'country': 'Austria', 'geoPoint': {'lat': 48.32829, 'lon': 16.05858}}, {'zip': '1070', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Dr. Brigitte Wiesenthal', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1070', 'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1200', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Dr. Wolfgang Bartl', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1200', 'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '8740', 'city': 'Zeltweg', 'country': 'Austria', 'facility': 'Dr. Walter Paulik', 'geoPoint': {'lat': 47.18333, 'lon': 14.75}}, {'zip': '8740', 'city': 'Zeltweg', 'country': 'Austria', 'geoPoint': {'lat': 47.18333, 'lon': 14.75}}, {'zip': '2018', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Dr. Philip Loquet', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2018', 'city': 'Antwerp', 'country': 'Belgium', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1070', 'city': 'Bruxelles-brussel', 'country': 'Belgium', 'facility': 'Hôpital Erasme/Erasmus Ziekenhuis'}, {'zip': '1070', 'city': 'Bruxelles-brussel', 'country': 'Belgium'}, {'zip': '2180', 'city': 'Ekeren', 'country': 'Belgium', 'facility': 'Gynaecologen Noord Antwerpen', 'geoPoint': {'lat': 51.28087, 'lon': 4.41813}}, {'zip': '2180', 'city': 'Ekeren', 'country': 'Belgium', 'geoPoint': {'lat': 51.28087, 'lon': 4.41813}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 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