Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H6D-GH-B022 | Other Identifier | Eli Lilly and Company |
Not provided
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The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will last about up to 25 months for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.5 mg/5 mg tadalafil | Experimental | 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). |
|
| 5 mg tadalafil | Experimental | 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) | A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Baseline through Month 12 |
| Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation | Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Baseline through Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Beijing | 100020 |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
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| ID | Title | Description |
|---|---|---|
| FG000 | 2.5 mg/5 mg Tadalafil | 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). |
| FG001 | 5 mg Tadalafil | 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Month 3) |
|
| ||||||||||||||||||||||||
| Period 2 (Month 3 to Month 12) |
| |||||||||||||||||||||||||
| Period 2 (Month 12 to Month 24) |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2.5 mg/5 mg Tadalafil | 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). |
| BG001 | 5 mg Tadalafil | 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) | A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil. | Posted | Number | Percentage of participants | Baseline through Month 12 |
|
Not provided
All the participants who received at least one dose of study drug.
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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 | 2.5 mg/5 mg Tadalafil | 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Baseline, Month 1; Baseline, Month 3 |
| Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect. | Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24 |
| Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary | Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. | Month 1, Month 3 |
| Percentage of Participants Achieving Normal Erectile Functioning | Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3. | Month 1, Month 3 |
| Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12. | Month 6, Month 12, Month 18, Month 24 |
| Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Participants with "yes" responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? | Month 3, Month12, Month 24 |
| China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Changchun | 130021 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Changsha | 410011 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chengdu | 610083 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chongqing | 400037 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fuzhou | 350001 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Guangzhou | 510180 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hangzhou | 310003 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hefei | 230022 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nanjing | 210008 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Qingdao | 266071 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shanghai | 200092 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Suzhou | 215004 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wenzhou | 325035 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wuhan | 430022 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wuhan | 430030 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Yinchuan | 750004 | China |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Sponsor Decision |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | 5 mg Tadalafil | 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2). |
|
|
| Primary | Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation | Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil. | Posted | Number | percentage of participants | Baseline through Month 12 |
|
|
|
| Secondary | Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect. | All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 1; Baseline, Month 3 |
|
|
|
| Secondary | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect. | All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24 |
|
|
|
| Secondary | Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary | Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. | All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data. | Posted | Mean | Standard Deviation | Percentage of participants | Month 1, Month 3 |
|
|
|
| Secondary | Percentage of Participants Achieving Normal Erectile Functioning | Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3. | All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data. | Posted | Number | Percentage of partcipants | Month 1, Month 3 |
|
|
|
| Secondary | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12. | All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data. | Posted | Number | Percentage of participants | Month 6, Month 12, Month 18, Month 24 |
|
|
|
| Secondary | Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Participants with "yes" responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? | All randomized participants who had evaluable data for Global Assessment Questions (GAQ)1 and GAQ2. | Posted | Number | percentage of participants | Month 3, Month12, Month 24 |
|
|
|
| 15 |
| 210 |
| 86 |
| 210 |
| EG001 | 5 mg Tadalafil | 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2). | 17 | 421 | 178 | 421 |
| Coronary artery disease | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Maculopathy | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Urethral stricture postoperative | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Varicocele | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Microvascular coronary artery disease | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| Excessive cerumen production | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| Mixed deafness | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Xerophthalmia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastric dilatation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Fatty liver alcoholic | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Dermatophytosis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Epididymitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Hepatitis b | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Infected dermal cyst | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Mumps | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Otitis media chronic | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Tinea manuum | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Electrical burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Peripheral nerve injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| High density lipoprotein increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Lipids increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vertebral lesion | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cerebral artery stenosis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Premature ejaculation | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Glomerulonephritis chronic | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Renal mass | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Urethral pain | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Epididymal cyst | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Reflux laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Breast feeding | Social circumstances | MedDRA 20.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Month 3 |
|
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| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Q2: successful penetration,Month 3 |
|
|
| Q3: successful intercourse,Month 1 |
|
|
| Q3: successful intercourse,Month 3 |
|
|
| Q4: satisfied with erection, Month 1 |
|
|
| Q4: satisfied with erection, Month 3 |
|
|
| Q5: satisfied with sexual experience,Month 1 |
|
|
| Q5: satisfied with sexual experience,Month 3 |
|
|
| Month 3 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 12: GAQ1 |
|
|
| Month 24: GAQ1 |
|
|
| Month 3: GAQ2 |
|
|
| Month 12: GAQ2 |
|
|
| Month 24: GAQ2 |
|
|