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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment.
This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment. After consent, all patients will get a tissue biopsy, and than half the patients will get fulvestrant alone (standard dosing) and the other half of the patients will get fulvestrant plus enzalutamide. At ~4 weeks, a biopsy will be done and therapy will be continued. Hormone therapy will continue for ~4 months at which point the patients will undergo surgical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fulvestrant Without Enzalutamide | Placebo Comparator | 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
|
| Fulvestrant With Enzalutamide | Experimental | 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With a PEPI Score Equal to Zero at Post Treatment | The preoperative endocrine prognostic index (PEPI) is a validated measure of pathologic response to endocrine therapy. It is a model that combines estrogen receptor (ER) level, pathologic tumor site, nodal status, and Ki67 score at the time of surgery to predict subsequent risk of cancer recurrence. PEPI scoring is typically discretized into three risk groups: 0 (low risk of recurrence and best outcome), 1-3 (intermediate risk), and >= 4 (high risk). This study was concerned only with the distinction between zero and non-zero PEPI scores. Zero is the minimum score, and there is no maximum score. Lower scores are better. | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | Disease-free survival is defined as the time in months from the start of fulvestrant until documented disease progression or death. Complete and partial response for the single drug arm and combination of enzalutamide/fulvestrant arm separately. | 15 months |
| Correlation Between PEPI Score and Disease-free Survival, Clinical Benefit Rate, and Overall Response Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony D Elias, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| Memorial Sloan Kettering Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21552212 | Background | Collins LC, Cole KS, Marotti JD, Hu R, Schnitt SJ, Tamimi RM. Androgen receptor expression in breast cancer in relation to molecular phenotype: results from the Nurses' Health Study. Mod Pathol. 2011 Jul;24(7):924-31. doi: 10.1038/modpathol.2011.54. Epub 2011 May 6. | |
| 25904752 | Background | Elebro K, Borgquist S, Simonsson M, Markkula A, Jirstrom K, Ingvar C, Rose C, Jernstrom H. Combined Androgen and Estrogen Receptor Status in Breast Cancer: Treatment Prediction and Prognosis in a Population-Based Prospective Cohort. Clin Cancer Res. 2015 Aug 15;21(16):3640-50. doi: 10.1158/1078-0432.CCR-14-2564. Epub 2015 Apr 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fulvestrant Without Enzalutamide | 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
| FG001 | Fulvestrant With Enzalutamide | 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily. Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant. Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fulvestrant Without Enzalutamide | 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
| BG001 | Fulvestrant With Enzalutamide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Patients With a PEPI Score Equal to Zero at Post Treatment | The preoperative endocrine prognostic index (PEPI) is a validated measure of pathologic response to endocrine therapy. It is a model that combines estrogen receptor (ER) level, pathologic tumor site, nodal status, and Ki67 score at the time of surgery to predict subsequent risk of cancer recurrence. PEPI scoring is typically discretized into three risk groups: 0 (low risk of recurrence and best outcome), 1-3 (intermediate risk), and >= 4 (high risk). This study was concerned only with the distinction between zero and non-zero PEPI scores. Zero is the minimum score, and there is no maximum score. Lower scores are better. | 59 patients were evaluable. One patient was unable to participate in treatment after baseline and the other came off study for treatment change. | Posted | Count of Participants | Participants | 16 Weeks |
|
51.78 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fulvestrant Without Enzalutamide | 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Elias | University of Colorado Hospital | 720-848-0300 | anthony.elias@cuasnchutz.edi |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 5, 2023 | May 17, 2023 | Prot_SAP_ICF_001.pdf |
Not provided
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Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
Not provided
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| Fulvestrant | Drug | 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
|
|
To assess the association between PEPI score and the clinical, outcomes such as DFS, ORR, clinical benefit for all subjects. |
| 4 years |
| Androgen Receptor (AR) Expression | The strength of AR signaling was measured by the percentage of downstream AR-regulated genes that were expressed. | 16 Weeks |
| New York |
| New York |
| 10065 |
| United States |
| West Cancer Center | Germantown | Tennessee | 38138 | United States |
| 21325075 | Background | Hu R, Dawood S, Holmes MD, Collins LC, Schnitt SJ, Cole K, Marotti JD, Hankinson SE, Colditz GA, Tamimi RM. Androgen receptor expression and breast cancer survival in postmenopausal women. Clin Cancer Res. 2011 Apr 1;17(7):1867-74. doi: 10.1158/1078-0432.CCR-10-2021. Epub 2011 Feb 15. |
| 24451109 | Background | Cochrane DR, Bernales S, Jacobsen BM, Cittelly DM, Howe EN, D'Amato NC, Spoelstra NS, Edgerton SM, Jean A, Guerrero J, Gomez F, Medicherla S, Alfaro IE, McCullagh E, Jedlicka P, Torkko KC, Thor AD, Elias AD, Protter AA, Richer JK. Role of the androgen receptor in breast cancer and preclinical analysis of enzalutamide. Breast Cancer Res. 2014 Jan 22;16(1):R7. doi: 10.1186/bcr3599. |
| 27565181 | Background | D'Amato NC, Gordon MA, Babbs B, Spoelstra NS, Carson Butterfield KT, Torkko KC, Phan VT, Barton VN, Rogers TJ, Sartorius CA, Elias A, Gertz J, Jacobsen BM, Richer JK. Cooperative Dynamics of AR and ER Activity in Breast Cancer. Mol Cancer Res. 2016 Nov;14(11):1054-1067. doi: 10.1158/1541-7786.MCR-16-0167. Epub 2016 Aug 26. |
| 20228125 | Background | Takagi K, Miki Y, Nagasaki S, Hirakawa H, Onodera Y, Akahira J, Ishida T, Watanabe M, Kimijima I, Hayashi S, Sasano H, Suzuki T. Increased intratumoral androgens in human breast carcinoma following aromatase inhibitor exemestane treatment. Endocr Relat Cancer. 2010 Apr 21;17(2):415-30. doi: 10.1677/ERC-09-0257. Print 2010 Jun. |
| Background | Elias A, Richer JK, LoRusso P, Peterson AC, Steinberg J, Mordenti J, Lopez C, Hudis C, Traina T. MDV3100-08: A phase 1 open-label, dose-escalation study evaluating the safety, tolerability, and pharmacokinetics of MDV3100 in women with incurable breast cancer. ASCO 2012, TPS668 |
| 22894553 | Background | Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15. |
| 26255746 | Background | Yeo B, Dowsett M. Neoadjuvant endocrine therapy: Patient selection, treatment duration and surrogate endpoints. Breast. 2015 Nov;24 Suppl 2:S78-83. doi: 10.1016/j.breast.2015.07.019. Epub 2015 Aug 6. |
| 23891267 | Background | Charehbili A, Fontein DB, Kroep JR, Liefers GJ, Mieog JS, Nortier JW, van de Velde CJ. Neoadjuvant hormonal therapy for endocrine sensitive breast cancer: a systematic review. Cancer Treat Rev. 2014 Feb;40(1):86-92. doi: 10.1016/j.ctrv.2013.06.001. Epub 2013 Jul 23. |
| 17538978 | Background | Semiglazov VF, Semiglazov VV, Dashyan GA, Ziltsova EK, Ivanov VG, Bozhok AA, Melnikova OA, Paltuev RM, Kletzel A, Berstein LM. Phase 2 randomized trial of primary endocrine therapy versus chemotherapy in postmenopausal patients with estrogen receptor-positive breast cancer. Cancer. 2007 Jul 15;110(2):244-54. doi: 10.1002/cncr.22789. |
| 21042932 | Background | von Minckwitz G, Untch M, Nuesch E, Loibl S, Kaufmann M, Kummel S, Fasching PA, Eiermann W, Blohmer JU, Costa SD, Mehta K, Hilfrich J, Jackisch C, Gerber B, du Bois A, Huober J, Hanusch C, Konecny G, Fett W, Stickeler E, Harbeck N, Muller V, Juni P. Impact of treatment characteristics on response of different breast cancer phenotypes: pooled analysis of the German neo-adjuvant chemotherapy trials. Breast Cancer Res Treat. 2011 Jan;125(1):145-56. doi: 10.1007/s10549-010-1228-x. Epub 2010 Nov 3. |
| 16622270 | Background | Kaufmann M, Hortobagyi GN, Goldhirsch A, Scholl S, Makris A, Valagussa P, Blohmer JU, Eiermann W, Jackesz R, Jonat W, Lebeau A, Loibl S, Miller W, Seeber S, Semiglazov V, Smith R, Souchon R, Stearns V, Untch M, von Minckwitz G. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: an update. J Clin Oncol. 2006 Apr 20;24(12):1940-9. doi: 10.1200/JCO.2005.02.6187. |
| 15701892 | Background | Dowsett M, Smith IE, Ebbs SR, Dixon JM, Skene A, Griffith C, Boeddinghaus I, Salter J, Detre S, Hills M, Ashley S, Francis S, Walsh G; IMPACT Trialists. Short-term changes in Ki-67 during neoadjuvant treatment of primary breast cancer with anastrozole or tamoxifen alone or combined correlate with recurrence-free survival. Clin Cancer Res. 2005 Jan 15;11(2 Pt 2):951s-8s. |
| 17912634 | Background | Ellis MJ, Ma C. Letrozole in the neoadjuvant setting: the P024 trial. Breast Cancer Res Treat. 2007;105 Suppl 1(Suppl 1):33-43. doi: 10.1007/s10549-007-9701-x. Epub 2007 Oct 3. |
| 26371134 | Background | Ellis MJ, Llombart-Cussac A, Feltl D, Dewar JA, Jasiowka M, Hewson N, Rukazenkov Y, Robertson JF. Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study. J Clin Oncol. 2015 Nov 10;33(32):3781-7. doi: 10.1200/JCO.2015.61.5831. Epub 2015 Sep 14. |
| 23065000 | Background | Robertson JF, Lindemann JP, Llombart-Cussac A, Rolski J, Feltl D, Dewar J, Emerson L, Dean A, Ellis MJ. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: follow-up analysis from the randomized 'FIRST' study. Breast Cancer Res Treat. 2012 Nov;136(2):503-11. doi: 10.1007/s10549-012-2192-4. Epub 2012 Oct 13. |
| 2702835 | Background | Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9. |
| 39368973 | Derived | Elias AD, Staley AW, Fornier M, Vidal GA, Alami V, Sams S, Spoelstra NS, Goodspeed A, Kabos P, Diamond JR, Shagisultanova E, Gallagher RI, Wulfkuhle JD, Petricoin EF, Zolman KL, McSpadden T, Jordan KR, Slansky JE, Borges VF, Gao D, Richer JK. Clinical and immune responses to neoadjuvant fulvestrant with or without enzalutamide in ER+/Her2- breast cancer. NPJ Breast Cancer. 2024 Oct 6;10(1):88. doi: 10.1038/s41523-024-00697-5. |
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily. Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant. Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
| OG001 | Fulvestrant With Enzalutamide | 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily. Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant. Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) |
|
|
| Secondary | Disease-free Survival | Disease-free survival is defined as the time in months from the start of fulvestrant until documented disease progression or death. Complete and partial response for the single drug arm and combination of enzalutamide/fulvestrant arm separately. | 59 patients were evaluable. One patient was unable to participate in treatment after baseline and the other came off study for treatment change. | Posted | Median | Full Range | months | 15 months |
|
|
|
| Secondary | Correlation Between PEPI Score and Disease-free Survival, Clinical Benefit Rate, and Overall Response Rate | To assess the association between PEPI score and the clinical, outcomes such as DFS, ORR, clinical benefit for all subjects. | Not Posted | 4 years | Participants |
| Secondary | Androgen Receptor (AR) Expression | The strength of AR signaling was measured by the percentage of downstream AR-regulated genes that were expressed. | The number of evaluable patients for this outcome measure is 49 because these were the patients who had available lab data for AR%. | Posted | Median | Full Range | percentage of genes expressed | 16 Weeks |
|
|
|
| 0 |
| 27 |
| 1 |
| 27 |
| 26 |
| 27 |
| EG001 | Fulvestrant With Enzalutamide | 500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily. Enzalutamide: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant. Fulvestrant: 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) | 0 | 34 | 3 | 34 | 34 | 34 |
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Hepatobiliary disorders | Systematic Assessment |
|
| Alkaline Phosphatase Increase | Hepatobiliary disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Arthralgia | Immune system disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Hepatobiliary disorders | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Chest Wall Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Cognitive Disturbance | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Creatinine increased | Renal and urinary disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Abdominal Cramping | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Hot flashes | Vascular disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Papular Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Weight Gain | Investigations | Systematic Assessment |
|
| decreased activity | General disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Maculo-papular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| tremor | Nervous system disorders | Systematic Assessment |
|
| Skin disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urinary issues | Renal and urinary disorders | Systematic Assessment |
|
| vaginal dryness | Reproductive system and breast disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| alanine transaminase increase | Investigations | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| agitation | Psychiatric disorders | Systematic Assessment |
|
| Anorgasmia | Psychiatric disorders | Systematic Assessment |
|
| Edema | General disorders | Systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Concentration Impairment | Nervous system disorders | Systematic Assessment |
|
| Confusion | Psychiatric disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Euphoria | Psychiatric disorders | Systematic Assessment |
|
| Eye disorders | Eye disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Hypertension | Surgical and medical procedures | Systematic Assessment |
|
| Ear infection | Infections and infestations | Systematic Assessment |
|
| Loss of Taste | Investigations | Systematic Assessment |
|
| Muscle pain | Investigations | Systematic Assessment |
|
| Restless Leg Syndrome | Investigations | Systematic Assessment |
|
| Cold intolerance | General disorders | Systematic Assessment |
|
| Neck tightness | General disorders | Systematic Assessment |
|
| restless hands | General disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Increase Urine Output | Renal and urinary disorders | Systematic Assessment |
|
| Decreased ROM | General disorders | Systematic Assessment |
|
| Laryngitis | Infections and infestations | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | Systematic Assessment |
|
| Decreased libido | Psychiatric disorders | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | Systematic Assessment |
|
| Weight Loss | Metabolism and nutrition disorders | Systematic Assessment |
|
| Pre-Diabeties | Metabolism and nutrition disorders | Systematic Assessment |
|
| Appetite Change | Metabolism and nutrition disorders | Systematic Assessment |
|
| Involuntary movement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Mucositis Oral | Gastrointestinal disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
|
| Oral Hemorrhage | Blood and lymphatic system disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Peripheral Sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Personality Change | Psychiatric disorders | Systematic Assessment |
|
| postnasal drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vaginal Bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| Respiratory issues | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Toothache | General disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Infection | Reproductive system and breast disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |