Time Frame |
From start of treatment until 36 months/EOS visit.
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
LCS12 (Skyla, BAY86-5028)
|
EE30/DRSP (Yasmin, BAY86-5131)
|
Arm/Group Description |
Participants received LCS12 (low do...
|
Participants received combined oral...
|
Arm/Group 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
|
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
|
|
LCS12 (Skyla, BAY86-5028)
|
EE30/DRSP (Yasmin, BAY86-5131)
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
|
|
LCS12 (Skyla, BAY86-5028)
|
EE30/DRSP (Yasmin, BAY86-5131)
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
22/279 (7.89%) |
5/281 (1.78%) |
Endocrine disorders |
|
|
Basedow's disease |
1/279 (0.36%) |
0/281 (0.00%) |
Basedow's disease |
1/279 (0.36%) |
0/281 (0.00%) |
Gastrointestinal disorders |
|
|
Colitis ulcerative |
1/279 (0.36%) |
0/281 (0.00%) |
Femoral hernia |
1/279 (0.36%) |
0/281 (0.00%) |
Colitis ulcerative |
1/279 (0.36%) |
0/281 (0.00%) |
Femoral hernia |
1/279 (0.36%) |
0/281 (0.00%) |
General disorders |
|
|
Impaired healing |
0/279 (0.00%) |
1/281 (0.36%) |
Impaired healing |
0/279 (0.00%) |
1/281 (0.36%) |
Infections and infestations |
|
|
Appendicitis |
1/279 (0.36%) |
2/281 (0.71%) |
Infectious mononucleosis |
0/279 (0.00%) |
1/281 (0.36%) |
Appendicitis |
1/279 (0.36%) |
2/281 (0.71%) |
Breast abscess |
1/279 (0.36%) |
0/281 (0.00%) |
Infectious mononucleosis |
0/279 (0.00%) |
1/281 (0.36%) |
Injury, poisoning and procedural complications |
|
|
Incisional hernia |
0/279 (0.00%) |
1/281 (0.36%) |
Laceration |
1/279 (0.36%) |
0/281 (0.00%) |
Muscle injury |
0/279 (0.00%) |
1/281 (0.36%) |
Ligament rupture |
1/279 (0.36%) |
0/281 (0.00%) |
Incisional hernia |
0/279 (0.00%) |
1/281 (0.36%) |
Laceration |
1/279 (0.36%) |
0/281 (0.00%) |
Muscle injury |
0/279 (0.00%) |
1/281 (0.36%) |
Ligament rupture |
2/279 (0.72%) |
0/281 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
Exostosis |
1/279 (0.36%) |
0/281 (0.00%) |
Nose deformity |
1/279 (0.36%) |
0/281 (0.00%) |
Exostosis |
1/279 (0.36%) |
0/281 (0.00%) |
Nose deformity |
1/279 (0.36%) |
0/281 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Malignant melanoma |
1/279 (0.36%) |
0/281 (0.00%) |
Cervix carcinoma stage 0 |
1/279 (0.36%) |
0/281 (0.00%) |
Borderline ovarian tumour |
1/279 (0.36%) |
0/281 (0.00%) |
Malignant melanoma |
1/279 (0.36%) |
0/281 (0.00%) |
Cervix carcinoma stage 0 |
1/279 (0.36%) |
0/281 (0.00%) |
Pregnancy, puerperium and perinatal conditions |
|
|
Abortion spontaneous |
1/279 (0.36%) |
1/281 (0.36%) |
Ectopic pregnancy |
1/279 (0.36%) |
0/281 (0.00%) |
Abortion spontaneous |
1/279 (0.36%) |
0/281 (0.00%) |
Ectopic pregnancy |
3/279 (1.08%) |
0/281 (0.00%) |
Reproductive system and breast disorders |
|
|
Cervical dysplasia |
1/279 (0.36%) |
0/281 (0.00%) |
Ovarian cyst |
1/279 (0.36%) |
0/281 (0.00%) |
Breast fibrosis |
1/279 (0.36%) |
0/281 (0.00%) |
Cervical dysplasia |
1/279 (0.36%) |
0/281 (0.00%) |
Ovarian cyst |
1/279 (0.36%) |
0/281 (0.00%) |
Surgical and medical procedures |
|
|
Breast prosthesis implantation |
1/279 (0.36%) |
0/281 (0.00%) |
Myomectomy |
1/279 (0.36%) |
0/281 (0.00%) |
Mammoplasty |
1/279 (0.36%) |
0/281 (0.00%) |
Indicates events were collected by non-systematic assessment
Term from vocabulary, MedDRA (15.1)
Term from vocabulary, MedDRA (17.0)
|
|
Frequency Threshold for Reporting Other Adverse Events
|
1%
|
|
LCS12 (Skyla, BAY86-5028)
|
EE30/DRSP (Yasmin, BAY86-5131)
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
215/279 (77.06%) |
148/281 (52.67%) |
Ear and labyrinth disorders |
|
|
Vertigo |
3/279 (1.08%) |
0/281 (0.00%) |
Vertigo |
3/279 (1.08%) |
0/281 (0.00%) |
Endocrine disorders |
|
|
Hypothyroidism |
3/279 (1.08%) |
2/281 (0.71%) |
Hypothyroidism |
3/279 (1.08%) |
2/281 (0.71%) |
Gastrointestinal disorders |
|
|
Abdominal pain |
23/279 (8.24%) |
4/281 (1.42%) |
Abdominal pain lower |
9/279 (3.23%) |
5/281 (1.78%) |
Abdominal pain upper |
3/279 (1.08%) |
6/281 (2.14%) |
Constipation |
0/279 (0.00%) |
4/281 (1.42%) |
Diarrhoea |
1/279 (0.36%) |
9/281 (3.20%) |
Gastritis |
4/279 (1.43%) |
4/281 (1.42%) |
Gastrooesophageal reflux disease |
3/279 (1.08%) |
3/281 (1.07%) |
Nausea |
9/279 (3.23%) |
14/281 (4.98%) |
Toothache |
3/279 (1.08%) |
2/281 (0.71%) |
Vomiting |
3/279 (1.08%) |
8/281 (2.85%) |
Abdominal pain |
21/279 (7.53%) |
4/281 (1.42%) |
Abdominal pain lower |
12/279 (4.30%) |
5/281 (1.78%) |
Abdominal pain upper |
3/279 (1.08%) |
6/281 (2.14%) |
Constipation |
0/279 (0.00%) |
4/281 (1.42%) |
Diarrhoea |
1/279 (0.36%) |
9/281 (3.20%) |
Gastritis |
5/279 (1.79%) |
4/281 (1.42%) |
Gastrooesophageal reflux disease |
5/279 (1.79%) |
3/281 (1.07%) |
Nausea |
9/279 (3.23%) |
14/281 (4.98%) |
Toothache |
4/279 (1.43%) |
2/281 (0.71%) |
Vomiting |
4/279 (1.43%) |
8/281 (2.85%) |
General disorders |
|
|
Irritability |
3/279 (1.08%) |
1/281 (0.36%) |
Pyrexia |
3/279 (1.08%) |
2/281 (0.71%) |
Pyrexia |
3/279 (1.08%) |
2/281 (0.71%) |
Infections and infestations |
|
|
Acute tonsillitis |
4/279 (1.43%) |
6/281 (2.14%) |
Bronchitis |
4/279 (1.43%) |
4/281 (1.42%) |
Cystitis |
17/279 (6.09%) |
15/281 (5.34%) |
Gastroenteritis |
2/279 (0.72%) |
4/281 (1.42%) |
Influenza |
2/279 (0.72%) |
3/281 (1.07%) |
Nasopharyngitis |
17/279 (6.09%) |
14/281 (4.98%) |
Sinusitis |
2/279 (0.72%) |
6/281 (2.14%) |
Tonsillitis |
3/279 (1.08%) |
4/281 (1.42%) |
Urinary tract infection |
11/279 (3.94%) |
5/281 (1.78%) |
Vaginal infection |
8/279 (2.87%) |
7/281 (2.49%) |
Vulvitis |
3/279 (1.08%) |
0/281 (0.00%) |
Vulvovaginal candidiasis |
13/279 (4.66%) |
7/281 (2.49%) |
Vulvovaginitis |
2/279 (0.72%) |
3/281 (1.07%) |
Tooth infection |
0/279 (0.00%) |
3/281 (1.07%) |
Vaginitis bacterial |
9/279 (3.23%) |
3/281 (1.07%) |
Vulvovaginal mycotic infection |
8/279 (2.87%) |
7/281 (2.49%) |
Vulvovaginitis streptococcal |
3/279 (1.08%) |
0/281 (0.00%) |
Acute tonsillitis |
5/279 (1.79%) |
6/281 (2.14%) |
Bacterial vaginosis |
18/279 (6.45%) |
3/281 (1.07%) |
Bronchitis |
5/279 (1.79%) |
4/281 (1.42%) |
Cystitis |
23/279 (8.24%) |
15/281 (5.34%) |
Ear infection |
3/279 (1.08%) |
0/281 (0.00%) |
Gastroenteritis |
5/279 (1.79%) |
4/281 (1.42%) |
Gonorrhoea |
3/279 (1.08%) |
0/281 (0.00%) |
Influenza |
5/279 (1.79%) |
3/281 (1.07%) |
Nasopharyngitis |
22/279 (7.89%) |
13/281 (4.63%) |
Sinusitis |
3/279 (1.08%) |
6/281 (2.14%) |
Tonsillitis |
7/279 (2.51%) |
4/281 (1.42%) |
Urinary tract infection |
14/279 (5.02%) |
4/281 (1.42%) |
Vaginal infection |
11/279 (3.94%) |
7/281 (2.49%) |
Vaginitis gardnerella |
4/279 (1.43%) |
1/281 (0.36%) |
Vulvitis |
3/279 (1.08%) |
0/281 (0.00%) |
Vulvovaginal candidiasis |
15/279 (5.38%) |
6/281 (2.14%) |
Vulvovaginitis |
4/279 (1.43%) |
3/281 (1.07%) |
Tooth infection |
0/279 (0.00%) |
3/281 (1.07%) |
Chlamydial infection |
3/279 (1.08%) |
1/281 (0.36%) |
Vulvovaginal mycotic infection |
10/279 (3.58%) |
7/281 (2.49%) |
Vulvovaginitis streptococcal |
3/279 (1.08%) |
0/281 (0.00%) |
Vaginitis chlamydial |
3/279 (1.08%) |
0/281 (0.00%) |
Candida infection |
4/279 (1.43%) |
2/281 (0.71%) |
Injury, poisoning and procedural complications |
|
|
Contusion |
0/279 (0.00%) |
3/281 (1.07%) |
Procedural pain |
10/279 (3.58%) |
1/281 (0.36%) |
Joint dislocation |
4/279 (1.43%) |
0/281 (0.00%) |
Contusion |
0/279 (0.00%) |
3/281 (1.07%) |
Procedural pain |
10/279 (3.58%) |
1/281 (0.36%) |
Investigations |
|
|
Smear cervix abnormal |
5/279 (1.79%) |
0/281 (0.00%) |
Weight decreased |
1/279 (0.36%) |
3/281 (1.07%) |
Weight increased |
7/279 (2.51%) |
8/281 (2.85%) |
Human papilloma virus test positive |
4/279 (1.43%) |
3/281 (1.07%) |
Smear cervix abnormal |
5/279 (1.79%) |
0/281 (0.00%) |
Weight decreased |
3/279 (1.08%) |
3/281 (1.07%) |
Weight increased |
10/279 (3.58%) |
8/281 (2.85%) |
Human papilloma virus test positive |
5/279 (1.79%) |
3/281 (1.07%) |
Chlamydia test positive |
4/279 (1.43%) |
2/281 (0.71%) |
Musculoskeletal and connective tissue disorders |
|
|
Back pain |
6/279 (2.15%) |
4/281 (1.42%) |
Back pain |
8/279 (2.87%) |
4/281 (1.42%) |
Nervous system disorders |
|
|
Headache |
21/279 (7.53%) |
33/281 (11.74%) |
Migraine |
2/279 (0.72%) |
5/281 (1.78%) |
Headache |
26/279 (9.32%) |
32/281 (11.39%) |
Migraine |
2/279 (0.72%) |
5/281 (1.78%) |
Psychiatric disorders |
|
|
Depression |
1/279 (0.36%) |
4/281 (1.42%) |
Insomnia |
0/279 (0.00%) |
4/281 (1.42%) |
Libido decreased |
1/279 (0.36%) |
3/281 (1.07%) |
Mood altered |
1/279 (0.36%) |
3/281 (1.07%) |
Depression |
2/279 (0.72%) |
4/281 (1.42%) |
Insomnia |
0/279 (0.00%) |
4/281 (1.42%) |
Irritability |
3/279 (1.08%) |
1/281 (0.36%) |
Libido decreased |
3/279 (1.08%) |
3/281 (1.07%) |
Mood altered |
1/279 (0.36%) |
3/281 (1.07%) |
Reproductive system and breast disorders |
|
|
Breast pain |
3/279 (1.08%) |
1/281 (0.36%) |
Breast tenderness |
3/279 (1.08%) |
2/281 (0.71%) |
Cervical dysplasia |
25/279 (8.96%) |
16/281 (5.69%) |
Dysmenorrhoea |
48/279 (17.20%) |
26/281 (9.25%) |
Menorrhagia |
5/279 (1.79%) |
5/281 (1.78%) |
Metrorrhagia |
9/279 (3.23%) |
1/281 (0.36%) |
Ovarian cyst |
19/279 (6.81%) |
0/281 (0.00%) |
Pelvic pain |
13/279 (4.66%) |
0/281 (0.00%) |
Vaginal discharge |
6/279 (2.15%) |
1/281 (0.36%) |
Vaginal haemorrhage |
6/279 (2.15%) |
0/281 (0.00%) |
Genital haemorrhage |
6/279 (2.15%) |
0/281 (0.00%) |
Coital bleeding |
3/279 (1.08%) |
1/281 (0.36%) |
Breast pain |
3/279 (1.08%) |
1/281 (0.36%) |
Breast tenderness |
3/279 (1.08%) |
2/281 (0.71%) |
Cervical dysplasia |
35/279 (12.54%) |
16/281 (5.69%) |
Dysmenorrhoea |
47/279 (16.85%) |
26/281 (9.25%) |
Dyspareunia |
4/279 (1.43%) |
0/281 (0.00%) |
Menorrhagia |
6/279 (2.15%) |
5/281 (1.78%) |
Metrorrhagia |
10/279 (3.58%) |
1/281 (0.36%) |
Ovarian cyst |
18/279 (6.45%) |
0/281 (0.00%) |
Ovarian cyst ruptured |
4/279 (1.43%) |
0/281 (0.00%) |
Pelvic pain |
13/279 (4.66%) |
0/281 (0.00%) |
Vaginal discharge |
12/279 (4.30%) |
0/281 (0.00%) |
Vaginal haemorrhage |
8/279 (2.87%) |
0/281 (0.00%) |
Vulvovaginal pruritus |
3/279 (1.08%) |
1/281 (0.36%) |
Genital haemorrhage |
6/279 (2.15%) |
0/281 (0.00%) |
Coital bleeding |
5/279 (1.79%) |
1/281 (0.36%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Cough |
1/279 (0.36%) |
3/281 (1.07%) |
Oropharyngeal pain |
5/279 (1.79%) |
2/281 (0.71%) |
Cough |
2/279 (0.72%) |
3/281 (1.07%) |
Oropharyngeal pain |
7/279 (2.51%) |
2/281 (0.71%) |
Skin and subcutaneous tissue disorders |
|
|
Acne |
30/279 (10.75%) |
6/281 (2.14%) |
Skin disorder |
3/279 (1.08%) |
0/281 (0.00%) |
Acne |
34/279 (12.19%) |
6/281 (2.14%) |
Rash |
3/279 (1.08%) |
0/281 (0.00%) |
Skin disorder |
3/279 (1.08%) |
0/281 (0.00%) |
Surgical and medical procedures |
|
|
Wisdom teeth removal |
4/279 (1.43%) |
1/281 (0.36%) |
Wisdom teeth removal |
5/279 (1.79%) |
1/281 (0.36%) |
Indicates events were collected by non-systematic assessment
Term from vocabulary, MedDRA (15.1)
Term from vocabulary, MedDRA (17.0)
|