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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005882-15 | EudraCT Number |
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Study early terminated due to low enrollment compared to the anticipated figures
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The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.
The purpose of this open-label, single arm, multi-center, Phase II interventional pilot trial was to evaluate if a decentralized clinical trial (DCT) using a telemedicine platform offers a satisfactory, safe and suitable management for HR-positive/HER2-negative participants with advanced breast cancer harboring a PIK3CA mutation and treated with alpelisib plus fulvestrant. The trial utilized a hybrid DCT approach to reduce participant burden by bringing visits, services, and supplies closer to them.
The planned duration of treatment was 12 cycles of 28 days. Participants could discontinue treatment earlier due to unacceptable toxicity, disease progression and/or decision made at the discretion of the investigator or the participant.
On-site visits occurred during screening, at Cycle 1 Day 1 (baseline), and at end-of-trial. Visits at the local oncologist practice were planned on Day 1 of Cycle 2, Cycle 4, Cycle 7, and Cycle 10. Other visits were performed by a district nurse, either at home or at the local oncologist's practice, depending on the participant's preference.
During the on-site visit on Cycle 1, Day 1, participants were trained on using the telemedicine platform, and other monitoring devices used during remote participation: a glucometer and a smartphone with the telemedicine application installed. Study treatment was also initiated during this visit. The participants were then transitioned to remote participation enabled by the telemedicine platform with support of local healthcare providers (local oncologist, district nurse, or other qualified healthcare professional) under the investigator's oversight.
Discontinuation of remote participation was not a reason for trial termination. Participants who did not wish to continue with remote participation had the option to attend on-site visits.
The study planned to enroll approximately 20 participants, however the study was terminated prematurely with only 2 participants enrolled. The decision to terminate the study was due to delays during the start-up period and due to low enrollment. The decision to terminate was not related to any potential safety concern with alpelisib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpelisib + fulvestrant | Experimental | Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpelisib | Drug | Participants received a daily oral dose of 300 mg of alpelisib film-coated tablets for a total of 12 cycles, with each cycle lasting 28 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction Assessed Through the Trial Feedback Questionnaire (TFQ) | The TFQ was designed to capture the patient's experience during a clinical trial. The questionnaire consisted of 23 questions that assessed various aspects of the trial experience. Each question in the TFQ scored on a scale ranging from 1 (representing the worst response) to 5 (representing the best response). To calculate the total score, the scores obtained from each of the 23 questions were summed up. The resulting sum represented the participant's total score, which could ranged from 23 (indicating the lowest possible score) to 115 (indicating the highest possible score). | Baseline, and on Day 1 of Cycle 4 and 7. Cycle= 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Retention on the Decentralized Clinical Trial (DCT) Approach | Patient retention on the DCT approach was calculated as the percentage of participants on remote monitoring for participants still on treatment | At 3 and 6 months |
| Number of Unscheduled In-clinic Visits |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Örebro | 701 85 | Sweden |
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| Label | URL |
|---|---|
| Patient Lay Trial Summary | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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The study was conducted in 1 center from Sweden
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| ID | Title | Description |
|---|---|---|
| FG000 | Alpelisib + Fulvestrant | Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 15, 2021 | Jun 21, 2023 |
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| Fulvestrant | Drug | Participants were administered fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and on Day 1 of each 28-day cycle thereafter until Cycle 12. |
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| Goserelin | Drug | Pre-menopausal women were administered a dose of 3.6 mg of goserelin injection via intramuscular route, beginning on Cycle 1 Day 1. Subsequently, the same dose was administered on Day 1 of each 28-day cycle throughout the study. |
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Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits was evaluated |
| From the date of the first study treatment up to the end of study, assessed up to 6 months |
| Number of Unscheduled In-clinic Visits Because of Safety Reasons | Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits that were prompted by safety reasons was evaluated | From the date of the first study treatment up to the end of study, assessed up to 6 months |
| Number of Unscheduled In-clinic Visits Per Participant in the Study | Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits per participants was evaluated | From the date of the first study treatment up to the end of study, assessed up to 6 months |
| Number of Participants Who Discontinue Treatment Due to Adverse Events (AEs) | An AE refers to any untoward medical occurrence, such as an unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease. The number of participants who discontinued the treatment due to adverse events was evaluated | From the date of the first study treatment up to the end of treatment, assessed up to 6 months |
| Number of Participants With Dose Reductions/Interruptions for Alpelisib | Number of participants with dose reductions and interruptions for alpelisib | From the date of the first study treatment up to the end of treatment, assessed up to 6 months |
| Number of Participants With Adverse Events of Special Interest (AESIs)- Hyperglycemia, Rash and Diarrhea | AESIs (Adverse Events of Special Interest) are defined as events, whether serious or non-serious, that are of scientific and medical concern specific to the sponsor's product or program. These events may require ongoing monitoring and communication by the investigator to the sponsor. For this study, the following AESIs were defined: hyperglycemia, rash, and diarrhea. The number of participants experiencing these events per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 was evaluated. | From the date of the first study treatment up to the end of study, assessed up to 6 months |
| Number of Participants With Adverse Events (AEs) Leading to In-clinic Visits | An AE refers to any untoward medical occurrence, such as an unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease. The number of participants with AEs per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 leading to in-clinic visits was assessed. | From the date of the first study treatment up to the end of study, assessed up to 6 months |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | The EORTC QLQ-C30 questionnaire contained 30 items and was composed of both multi-item scales and single item measures. These included five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/quality of life (QoL) scale. All of the scales and single items ranged from 0 to 100. A high scale score represented a higher response level. Thus, a high score for a functional scale indicated a high/healthy level of functioning, a high score for the QoL indicated high QoL, but a high score for a symptom scale/single item indicated a high level of symptomatology/problems. The EORTC QLQ-C30 scores for all functional and symptom scales were evaluated | Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual Analog Scale (VAS) Score | The 5-level EQ-5D (EQ-5D-5L) questionnaire is a standardized measure of health status. The EQ-5D descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The EQ-5D-5L VAS scores were evaluated | Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days |
| Brief Pain Inventory Short Form (BPI-SF) Scores | The BPI-SF was a questionnaire used to assess pain intensity and interference with daily activities. The Pain Severity Subscale included four questions asking individuals to rate their pain intensity on a scale from 0 to 10, with higher scores indicating more severe pain. The Pain Interference Subscale consisted of seven items that assessed how pain had interfered with activities, rated on the same scale. Both subscales had a total score range of 0 to 10, with higher scores indicating more significant pain or interference. | Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days |
| Number of Participants With Progression-free Survival (PFS) According to RECIST 1.1 | The number of participants with PFS was defined as the count of participants who did not experience disease progression or death due to any cause during the study. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on local radiology review. | Up to 6 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alpelisib + Fulvestrant | Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Gender details were not collected from any participant | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Participant Satisfaction Assessed Through the Trial Feedback Questionnaire (TFQ) | The TFQ was designed to capture the patient's experience during a clinical trial. The questionnaire consisted of 23 questions that assessed various aspects of the trial experience. Each question in the TFQ scored on a scale ranging from 1 (representing the worst response) to 5 (representing the best response). To calculate the total score, the scores obtained from each of the 23 questions were summed up. The resulting sum represented the participant's total score, which could ranged from 23 (indicating the lowest possible score) to 115 (indicating the highest possible score). | All enrolled participants who received at least one dose of any component of study treatment | Posted | Median | Full Range | Score on a Scale | Baseline, and on Day 1 of Cycle 4 and 7. Cycle= 28 days |
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| Secondary | Patient Retention on the Decentralized Clinical Trial (DCT) Approach | Patient retention on the DCT approach was calculated as the percentage of participants on remote monitoring for participants still on treatment | Participants receiving treatment at the specified time points | Posted | Count of Participants | Participants | At 3 and 6 months |
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| Secondary | Number of Unscheduled In-clinic Visits | Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits was evaluated | All enrolled participants who received at least one dose of any component of study treatment | Posted | Number | Visits | From the date of the first study treatment up to the end of study, assessed up to 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Unscheduled In-clinic Visits Because of Safety Reasons | Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits that were prompted by safety reasons was evaluated | All enrolled participants who received at least one dose of any component of study treatment | Posted | Median | Full Range | Visits | From the date of the first study treatment up to the end of study, assessed up to 6 months |
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| ||||||||||||||||||||||||||||
| Secondary | Number of Unscheduled In-clinic Visits Per Participant in the Study | Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital). The total number of unscheduled in-clinic visits per participants was evaluated | All enrolled participants who received at least one dose of any component of study treatment | Posted | Median | Full Range | Visits per participant | From the date of the first study treatment up to the end of study, assessed up to 6 months |
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| Secondary | Number of Participants Who Discontinue Treatment Due to Adverse Events (AEs) | An AE refers to any untoward medical occurrence, such as an unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease. The number of participants who discontinued the treatment due to adverse events was evaluated | All enrolled participants who received at least one dose of any component of study treatment | Posted | Count of Participants | Participants | From the date of the first study treatment up to the end of treatment, assessed up to 6 months |
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| Secondary | Number of Participants With Dose Reductions/Interruptions for Alpelisib | Number of participants with dose reductions and interruptions for alpelisib | All enrolled participants who received at least one dose of any study treatment | Posted | Count of Participants | Participants | From the date of the first study treatment up to the end of treatment, assessed up to 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events of Special Interest (AESIs)- Hyperglycemia, Rash and Diarrhea | AESIs (Adverse Events of Special Interest) are defined as events, whether serious or non-serious, that are of scientific and medical concern specific to the sponsor's product or program. These events may require ongoing monitoring and communication by the investigator to the sponsor. For this study, the following AESIs were defined: hyperglycemia, rash, and diarrhea. The number of participants experiencing these events per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 was evaluated. | All enrolled participants who received at least one dose of any study treatment | Posted | Count of Participants | Participants | From the date of the first study treatment up to the end of study, assessed up to 6 months |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) Leading to In-clinic Visits | An AE refers to any untoward medical occurrence, such as an unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease. The number of participants with AEs per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 leading to in-clinic visits was assessed. | All enrolled participants who received at least one dose of any study treatment | Posted | Count of Participants | Participants | From the date of the first study treatment up to the end of study, assessed up to 6 months |
|
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| Secondary | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | The EORTC QLQ-C30 questionnaire contained 30 items and was composed of both multi-item scales and single item measures. These included five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/quality of life (QoL) scale. All of the scales and single items ranged from 0 to 100. A high scale score represented a higher response level. Thus, a high score for a functional scale indicated a high/healthy level of functioning, a high score for the QoL indicated high QoL, but a high score for a symptom scale/single item indicated a high level of symptomatology/problems. The EORTC QLQ-C30 scores for all functional and symptom scales were evaluated | All enrolled participants who received at least one dose of any study treatment. Number analyzed indicates the number of participants with data available at the designated time point. | Posted | Median | Full Range | Score on a Scale | Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days |
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| Secondary | EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual Analog Scale (VAS) Score | The 5-level EQ-5D (EQ-5D-5L) questionnaire is a standardized measure of health status. The EQ-5D descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The EQ-5D-5L VAS scores were evaluated | All enrolled participants who received at least one dose of any study treatment. Number analyzed indicates the number of participants with data available at the designated time point. | Posted | Median | Full Range | Score on a scale | Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days |
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| Secondary | Brief Pain Inventory Short Form (BPI-SF) Scores | The BPI-SF was a questionnaire used to assess pain intensity and interference with daily activities. The Pain Severity Subscale included four questions asking individuals to rate their pain intensity on a scale from 0 to 10, with higher scores indicating more severe pain. The Pain Interference Subscale consisted of seven items that assessed how pain had interfered with activities, rated on the same scale. Both subscales had a total score range of 0 to 10, with higher scores indicating more significant pain or interference. | All enrolled participants who received at least one dose of any study treatment. Number analyzed indicates the number of participants with data available at the designated time point. | Posted | Median | Full Range | Score on a scale | Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days |
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| Secondary | Number of Participants With Progression-free Survival (PFS) According to RECIST 1.1 | The number of participants with PFS was defined as the count of participants who did not experience disease progression or death due to any cause during the study. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on local radiology review. | All enrolled participants who received at least one dose of any component of study treatment | Posted | Count of Participants | Participants | No | Up to 6 months |
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From start up to end of study, assessed up to 6 months
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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 | Alpelisib + Fulvestrant | Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle. | 0 | 2 | 0 | 2 | 2 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2022 | Jun 21, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C585539 | Alpelisib |
| D000077267 | Fulvestrant |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | 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 |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| Cycle 7 Day 1 |
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