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| ID | Type | Description | Link |
|---|---|---|---|
| 311963 | Other Identifier | Company internal | |
| 2014-004612-10 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne vulgaris over 6 treatment cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Experimental | In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol). |
|
| Placebo | Placebo Comparator | The participants of the placebo group received inert but identical-appearing, color-matched tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Drug | 20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set) | Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
| Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set) | Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou | Guangdong | 510630 | China | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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193 participants screened, 14 failed screening: withdrawal of consent (7), inclusion/exclusion criteria not met (6), participant lost/no further information available (1). study drug intake was unknown (3) and 3 participants to whom study drug was never administered (withdrawal of consent or lost to follow-up) were excluded from FAS.
Analyzed: 179 participants randomized, 173 in the FAS (Full Analysis Set): 87 in YAZ, 86 in placebo groups, 143 in the PPS (Per Protocol Set): 74 in YAZ, 69 in placebo groups
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| ID | Title | Description |
|---|---|---|
| FG000 | EE20/Drospirenone (YAZ, BAY86-5300) | In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol). |
| FG001 | Placebo | The participants of the placebo group received inert but identical-appearing, color-matched tablets. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EE20/Drospirenone (YAZ, BAY86-5300) | In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol). |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of participants was derived from birth date entered onto CRF (Case Report Form) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set) | Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change. | FAS | Posted | Mean | Standard Deviation | Percent change | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EE20/Drospirenone (YAZ, BAY86-5300) | In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
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| Placebo | Drug | Inert tablet |
|
| Screening visit |
| Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1 | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | Cycle 1 (Day 15±3 days of Treatment Cycle 1) |
| Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3 | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | Cycle 3 (Day 15±3 days of Treatment Cycle 3) |
| Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6 | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | Cycle 6 (Day 15±3 days of Treatment Cycle 6) |
| Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count | Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (lesion count at Baseline - lesion count at Cycle 6)/(lesion count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
| Percent Change From Cycle 6 to Baseline in Lesion Count of Papules | Acne lesions were counted by the trained designee over the entire face. All papules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (papule count at Baseline - papule count at Cycle 6)/(papule count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
| Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules | Acne lesions were counted by the trained designee over the entire face. All pustules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (pustule count at Baseline - pustule count at Cycle 6)/(pustule count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
| Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules | Acne lesions were counted by the trained designee over the entire face. All nodules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (nodule count at Baseline - nodule count at Cycle 6)/(nodule count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
| Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones | Acne lesions were counted by the trained designee over the entire face. All open comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (open comedone count at Baseline -open comedone count at Cycle 6)/(open comedone count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
| Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones | Acne lesions were counted by the trained designee over the entire face. All closed comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (closed comedone count at Baseline - closed comedone count at Cycle 6)/(closed comedone count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
| Percentage of Participants Classified as "Improved" According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating | The proportion of participants rated as "improved" comprises those with complete remission, excellent, marked, or moderate improvement according to the Investigator's Overall Improvement Rating and those with excellent, good, or fair improvement the Participant's Overall Self-Assessment Rating. No improvement or deterioration (worsening of disease signs and symptoms compared to Baseline in the view of investigator/subject) comprise "not improved" status. | At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle) |
| Changsha |
| Hunan |
| 410011 |
| China |
| Nanjing | Jiangsu | 210042 | China |
| Chengdu | Sichuan | 610041 | China |
| Beijing | 100032 | China |
| Beijing | 100853 | China |
| Shanghai | 200043 | China |
| Protocol Violation |
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| Pregnancy |
|
| Withdrawal by Subject |
|
| participant recovered completely |
|
| participant will leave for long tme |
|
The participants of the placebo group received inert but identical-appearing, color-matched tablets. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | The participants of the placebo group received inert but identical-appearing, color-matched tablets. |
|
|
| Primary | Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set) | Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change. | PPS | Posted | Mean | Standard Deviation | Percent change | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
|
|
|
| Secondary | Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | Full analysis set at screening | Posted | Number | Percentage of participants | Screening visit |
|
|
|
| Secondary | Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1 | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | FAS, all participants with data for Cycle 1 | Posted | Number | Percentage of participants | Cycle 1 (Day 15±3 days of Treatment Cycle 1) |
|
|
|
| Secondary | Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3 | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | FAS, all participants with data for Cycle 3 | Posted | Number | Percentage of participants | Cycle 3 (Day 15±3 days of Treatment Cycle 3) |
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| Secondary | Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6 | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | FAS, all participants with data for Cycle 6 | Posted | Number | Percentage of participants | Cycle 6 (Day 15±3 days of Treatment Cycle 6) |
|
|
|
| Secondary | Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count | Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (lesion count at Baseline - lesion count at Cycle 6)/(lesion count at Baseline)*100, so that improvement is indicated by a larger percent change. | FAS (due to missing data number of participants differs from number at Baseline) | Posted | Mean | Standard Deviation | Percent change | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
|
|
|
| Secondary | Percent Change From Cycle 6 to Baseline in Lesion Count of Papules | Acne lesions were counted by the trained designee over the entire face. All papules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (papule count at Baseline - papule count at Cycle 6)/(papule count at Baseline)*100, so that improvement is indicated by a larger percent change. | FAS (due to missing data number of participants differs from number at Baseline) | Posted | Mean | Standard Deviation | Percent change | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
|
|
|
| Secondary | Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules | Acne lesions were counted by the trained designee over the entire face. All pustules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (pustule count at Baseline - pustule count at Cycle 6)/(pustule count at Baseline)*100, so that improvement is indicated by a larger percent change. | FAS (due to missing data number of participants differs from number at Baseline) | Posted | Mean | Standard Deviation | Percent change | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
|
|
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| Secondary | Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules | Acne lesions were counted by the trained designee over the entire face. All nodules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (nodule count at Baseline - nodule count at Cycle 6)/(nodule count at Baseline)*100, so that improvement is indicated by a larger percent change. | FAS (due to missing data number of participants differs from number at Baseline) | Posted | Mean | Standard Deviation | Percent change | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
|
|
|
| Secondary | Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones | Acne lesions were counted by the trained designee over the entire face. All open comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (open comedone count at Baseline -open comedone count at Cycle 6)/(open comedone count at Baseline)*100, so that improvement is indicated by a larger percent change. | FAS (due to missing data number of participants differs from number at Baseline) | Posted | Mean | Standard Deviation | Percent change | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
|
|
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| Secondary | Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones | Acne lesions were counted by the trained designee over the entire face. All closed comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (closed comedone count at Baseline - closed comedone count at Cycle 6)/(closed comedone count at Baseline)*100, so that improvement is indicated by a larger percent change. | FAS (due to missing data number of participants differs from number at Baseline) | Posted | Mean | Standard Deviation | Percent change | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline |
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| Secondary | Percentage of Participants Classified as "Improved" According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating | The proportion of participants rated as "improved" comprises those with complete remission, excellent, marked, or moderate improvement according to the Investigator's Overall Improvement Rating and those with excellent, good, or fair improvement the Participant's Overall Self-Assessment Rating. No improvement or deterioration (worsening of disease signs and symptoms compared to Baseline in the view of investigator/subject) comprise "not improved" status. | FAS (due to missing data number of participants differs from number at Baseline) | Posted | Number | Percentage of participants | At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle) |
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|
| 0 |
| 87 |
| 34 |
| 87 |
| EG001 | Placebo | The participants of the placebo group received inert but identical-appearing, color-matched tablets. | 0 | 86 | 19 | 86 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Cervicitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pelvic inflammatory disease | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Papilloma viral infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
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| Glycosylated haemoglobin increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
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| Red blood cells urine positive | Investigations | MedDRA 13.0 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA 13.0 | Non-systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Breast mass | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hypomenorrhoea | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Menstrual disorder | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Menstruation delayed | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Oligomenorrhoea | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
Not provided