Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-IN-JPEC | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer. Participants must have hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer and must live in India. For each participant, the study could last up to eight months and may include up to eight visits to the study center.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib + NSAI or Fulvestrant | Experimental | Participants received abemaciclib 150 milligram (mg) orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus either NSAI (nonsteroidal aromatase inhibitors - anastrozole or letrozole) administered orally as per standard of care or fulvestrant administered intramuscularly as per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event | Treatment-emergent adverse events (TEAEs) are defined as any adverse events that started at the time of, or after the, first study medication administration as well as those events that started prior to the first study drug administration, but which worsened after the first study medication administration. The reported data reflects the unique percentage of participants who experienced any serious and other non-serious adverse events. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Baseline until end of follow-up (Up To 7 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Baseline until end of study treatment (Up To 6 Months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| MNJ Institute of Oncology | Hyderabad | Andhra Pradesh | 500004 | India | ||
| Indira Gandhi Institute of Medical Sciences |
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 European union (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.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Abemaciclib + NSAI | Participants received abemaciclib 150 milligram (mg) orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care. |
| FG001 | Abemaciclib + Fulvestrant | Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus fulvestrant administered intramuscularly as per standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abemaciclib + NSAI | Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care. |
| 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 | Treatment-emergent adverse events (TEAEs) are defined as any adverse events that started at the time of, or after the, first study medication administration as well as those events that started prior to the first study drug administration, but which worsened after the first study medication administration. The reported data reflects the unique percentage of participants who experienced any serious and other non-serious adverse events. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline until end of follow-up (Up To 7 Months) |
|
Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
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 | Abemaciclib + NSAI | Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2021 | Sep 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2021 | Sep 22, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000590451 | abemaciclib |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nonsteroidal Aromatase Inhibitor (NSAI) | Drug | Letrozole or anastrozole administered orally (physician choice) |
|
| Fulvestrant | Drug | Administered intramuscularly |
|
| Patna |
| Bihar |
| 800014 |
| India |
| Nirmal Hospital Pvt Ltd. | Surat | Gujarat | 395002 | India |
| Unique Hospital Multispecialty & Research Institute | Surat | Gujarat | 395002 | India |
| Kailash Cancer Hospital & Research Centre (KCHRC) | Waghodia | Gujarat | 391760 | India |
| HCG Cancer Centre, Kalinga Rao Road | Bengaluru | Karnataka | 560020 | India |
| Regional Cancer Centre | Trivandrum | Kerala | 695011 | India |
| SRJ-CBCC Cancer Hospital | Indore | Madhya Pradesh | 452001 | India |
| Kingsway Hospital | Nagpur | Maharashtra | 440001 | India |
| Meditrina Institute of Medical Sciences | Nagpur | Maharashtra | 440012 | India |
| HCG Manavata Cancer Centre | Nashik | Maharashtra | 422001 | India |
| Ruby Hall Clinic and Grant Medical Foundation | Pune | Maharashtra | 411001 | India |
| Rajiv Gandhi Cancer Institute And Research Centre | New Delhi | National Capital Territory of Delhi | 110085 | India |
| Apollo Gleneagles Hospitals Kolkata | Kolkata | West Bengal | 700054 | India |
| Max Superspeciality Hospital | Chandigarh | 160055 | India |
| Protocol Violation |
|
| Adverse Event |
|
| Death |
|
| Non-compliance with study drug |
|
| Progressive disease |
|
| BG001 |
| Abemaciclib + Fulvestrant |
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus Fulvestrant administered intramuscularly as per standard of care. |
| 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 | Abemaciclib + Fulvestrant | Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus Fulvestrant administered intramuscularly as per standard of care. |
|
|
| Secondary | Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline until end of study treatment (Up To 6 Months) |
|
|
|
| 3 |
| 137 |
| 9 |
| 137 |
| 105 |
| 137 |
| EG001 | Abemaciclib + Fulvestrant | Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus Fulvestrant administered intramuscularly as per standard of care. | 1 | 63 | 5 | 63 | 44 | 63 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Covid-19 pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Central serous chorioretinopathy | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Swelling face | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Cystatin c increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Electrocardiogram qt prolonged | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Vitamin b12 decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Mediastinal mass | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |