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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003065-17 | EudraCT Number |
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The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.
Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.
This was an open-label, phase II, multicenter, international, single-arm study for postmenopausal women with ER+/HER2- metastatic or locally advanced breast cancer.
This study was comprised of 2 phases:
- Core Phase: from first participant first visit to 24 months after enrollment of the last participant (and upon approval of amendment 5 dated 14-Feb-2017), up to approximately 4 years. The main purpose of the amendment 5 was to implement an Extension Phase up to 3 years.
During the core phase, all enrolled participants received everolimus in combination with letrozole in the first line setting until disease progression or any other reason for which the participant might be discontinued. Only those participants who had disease progression in the first line setting were offered second line treatment (everolimus in combination with exemestane). Participants who discontinued first line treatment due to reasons other than disease progression were not eligible for second line treatment. The participants who were treated in the second line setting continued treatment until disease progression, unacceptable toxicity or withdrawal of consent.
- Extension Phase: Participants that were still benefiting from everolimus at the end of the Core Phase (and upon approval of amendment 5 dated 14-Feb-2017) were transitioned to the Extension phase of the study. Participants were continued on their existing line of treatment (everolimus plus letrozole or everolimus plus exemestane) in the extension, up to 3 years or until progression or any other reason for which the participant might be discontinued. Participants entering the Extension Phase on first line treatment and deemed to no longer be clinically benefiting were not offered second line treatment in the context of the study
This study included a randomized, open-label sub-study for participants in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution was commercially available who experienced a stomatitis event: at the first onset of symptoms suggestive of stomatitis, participants were to contact the study site and based on preliminary confirmation of diagnosis, participants were asked to visit the study site within 24 hours. Upon confirmation of stomatitis, participants in countries where the alcohol-free 0.5 mg/5 mL dexamethasone oral solution was commercially available (US sites only) were randomly assigned in a 1:1 ratio to take either 0.5 mg/5 mL dexamethasone mouth rinse or the standard of care used to treat stomatitis at the participant's center.
All participants who experienced stomatitis (regardless of inclusion in the sub-study) were instructed to fill out the Oral Stomatitis Daily Questionnaire (OSDQ) at home every day until the participant recovered. For subsequent episodes of stomatitis, participants were instructed to contact the physician. If part of the randomized set upon telephone confirmation, they were instructed to utilize the same treatment they were assigned to after the first episode and complete the OSDQ booklet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus+letrozole/exemestane (first line and second line treatment) | Experimental | Participants received everolimus in combination with letrozole as first-line treatment. Only participants who had disease progression in the first line setting (core phase) were offered second-line treatment (everolimus in combination with exemestane) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Everolimus was self-administered as a daily dose of 10mg (two 5mg tablets) taken orally continuously until progression of disease, unacceptable toxicity or withdrawal of consent. |
| Measure | Description | Time Frame |
|---|---|---|
| First-line Treatment: Progression-free Survival (PFS) | PFS in the first line setting is defined as the time from the date of enrollment to the date of first documented progression based on local radiology review or death due to any cause. If a participant did not progress or was not known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. The median PFS was estimated and presented along with 95% confidence intervals. The primary analysis of PFS for first line was performed 12 months after the last patient's recruitment. | From the date of enrollment to the date of first documented progression or deaths, assessed up to approximately 2.8 years |
| Measure | Description | Time Frame |
|---|---|---|
| First-line Treatment: Overall Response Rate (ORR) | ORR in first line setting is defined as the percentage of participants while on first-line treatment with best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.0 based on local review. Confidence intervals were calculated based on the Exact Clopper-Pearson method. ORR while on first-line treatment was assessed up to 24 months after the last patient's recruitment. CR: disappearance of all target lesions PR: at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria might apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Comprehensive Cancer Center SC-2 | Birmingham | Alabama | 35294 | United States | ||
| Banner MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29566104 | Derived | Royce M, Bachelot T, Villanueva C, Ozguroglu M, Azevedo SJ, Cruz FM, Debled M, Hegg R, Toyama T, Falkson C, Jeong J, Srimuninnimit V, Gradishar WJ, Arce C, Ridolfi A, Lin C, Cardoso F. Everolimus Plus Endocrine Therapy for Postmenopausal Women With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: A Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):977-984. doi: 10.1001/jamaoncol.2018.0060. |
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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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A total of 245 participants were screened of which 202 participants were enrolled in this study to receive study treatment.
The study was conducted across 52 centers in 13 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus+Letrozole/Exemestane (First-line Treatment and Second-line Treatment) | Participants received everolimus in combination with letrozole as first line treatment. Only participants who had disease progression in the first line setting (core phase) were offered second-line treatment (everolimus in combination with exemestane) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Line Treatment (Core+Extension) |
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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 | Feb 14, 2017 | Jan 12, 2022 |
The main study was an open-label single-arm study. The stomatitis sub-study was a randomized open-label study with two arms: dexamethasone and standard of care.
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| Letrozole | Drug | 1st line study treatment: Letrozole was self administered as a daily dose of 2.5mg continuously until disease progression or any other reason for which the patient might be discontinued |
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| Exemestane | Drug | 2nd Line Study Treatment: Exemestane was self administered as a daily dose of 25mg taken orally continuously until disease progression or any other reason for which the patient might be discontinued |
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| Alcohol-free dexamethasone mouth rinse (Stomatitis sub-study) | Drug | Alcohol-free 0.5mg/5ml dexamethasone oral solution was self-administered at a daily dose of 10ml 3 times per day (participants with confirmed stomatitis who entered the stomatitis sub-study). |
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| Standard of care to treat stomatitis (Stomatitis sub-study) | Drug | Standard of care used to treat stomatitis at the patient's center (participants with confirmed stomatitis who entered the stomatitis sub-study). |
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| From the date of enrollment until discontinuation of first-line treatment, assessed up to approximately 3.8 years |
| First-line Treatment: Clinical Benefit Rate (CBR) | CBR in first line is defined as the percentage of participants while on first-line treatment with best overall response of CR, PR or stable disease (SD) with a duration of 24 weeks or longer, according to RECIST version 1.0 based on local review. Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. CBR while on first-line treatment was assessed up to 24 months after the last patient's recruitment. CR: disappearance of all target lesions PR: at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease | From the date of enrollment until first-line treatment discontinuation, assessed up to approximately 3.8 years |
| Second-line Treatment: Progression-free Survival (PFS) | PFS in the second line setting is defined as the time interval between the start of the second-line treatment and documented disease progression based on local radiology review or death due to any cause reported during or after second-line treatment period. If a participant did not progress or was not known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. The median PFS was estimated and presented along with 95% confidence intervals. PFS while on second-line treatment was assessed up to 24 months after the last patient's recruitment. | From the start of the second-line treatment until the date of first documented progression or death, assessed up to approximately 2.4 years |
| Second-line Treatment: Overall Response Rate (ORR) | ORR in second line is defined as the percentage of participants receiving second-line study treatment with best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.0 based on local review. Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. ORR while on second-line treatment was assessed up to 24 months after the last patient's recruitment. CR: disappearance of all target lesions PR: at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters | From the start of the second-line treatment up to approximately 2.4 years |
| Second-line Treatment: Clinical Benefit Rate (CBR) | CBR in second line is defined as the percentage of participants receiving second-line study treatment with best overall response of CR, PR or stable disease (SD) with a duration of 24 weeks or longer, according to RECIST version 1.0 based on local review. Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. CBR while on second-line treatment was assessed up to 24 months after the last patient's recruitment. CR: disappearance of all target lesions PR: at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease | From the start of the second-line treatment up to approximately 2.4 years |
| Overall Survival (OS) | OS following first-line treatment with everolimus + letrozole is defined as the time from the date of receiving first line study treatment to date of death due to any cause (including first-line and second-line treatment periods). If a participant was not known to have died, survival was censored at the date of last contact. OS following first-line treatment was assessed up to 24 months after last patient's recruitment. | From the date of enrollment to date of death, assessed up to approximately 3.8 years |
| First-line Treatment: Time to First Stomatitis Episode as Assessed by the Oral Stomatitis Daily Questionnaire (OSDQ) | The time to first occurrence of stomatitis based on OSDQ is defined as time from first-line treatment administration to start date of the stomatitis episode recorded in the OSDQ in the first line. The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The first item asked the participants when they experienced the first symptoms of stomatitis. Start date of the first occurrence of stomatitis is defined as the first date ever recorded for this item in the questionnaire. Patient reported outcomes (PROs) were assessed up to 24 months after last patient's recruitment. | From first-line treatment administration until first stomatitis episode in the first line, assessed up to approximately 3.8 years |
| First-line Treatment: Duration of First Stomatitis Based on OSDQ | The duration of the first stomatitis episode was calculated using the start and end date recorded in the OSDQ. The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis. The first item of the questionnaire asked the participants the date when they experienced the first symptoms of stomatitis. Start date of the first occurrence of stomatitis is defined as the first date ever recorded for this item in the questionnaire. Stop date of the first stomatitis episode is defined as the last date the OSDQ was completed for this episode. Participants were censored if they died before resolution of stomatitis, received a new anticancer therapy, discontinued the study treatment with no resolution of the stomatitis or the stomatitis event was still on-going at the cut-off. PROs were assessed up to 24 months after last patient's recruitment. | From start date of first stomatitis episode in first line until its resolution, assessed up to 3.8 years |
| First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Overall Health at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily up to the resolution of the stomatitis episode. The second item asked the participant to rate their overall health from 0 (worst possible) to 10 (perfect health). The overall health OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
| First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The third item asked the participant to rate their mouth and throat soreness from 0 (no soreness) to 4 (extreme soreness). The mouth and throat soreness OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
| First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness Limiting Swallowing, Drinking, Eating, Talking and Sleeping at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The fourth item asked the participant to rate how much their mouth and throat soreness limited them in 1) swallowing, 2) drinking, 3) eating, 4) talking and 5) sleeping. For each activity, mouth and throat soreness scores ranged from 0 (not limited) to 4 (unable to do). Scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
| First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The fifth item asked the participant to rate their mouth pain severity from 0 (no pain) to 10 (unbearable pain). The mouth pain severity OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
| First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity Affecting Daily Activities at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The sixth item asked the participant to rate their mouth pain severity affecting daily activities score from 0 (no effect on daily activities) to 10 (completely prevented from doing daily activities). The mouth pain severity affecting daily activities OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
| First-line Treatment (Stomatitis Sub-study): Time to First Stomatitis Episode as Assessed by the OSDQ | The time to first occurrence of stomatitis based on OSDQ is defined as time from first study treatment administration in the first line to start date of the first stomatitis episode recorded in the OSDQ. The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The first item asked the participants when they experienced the first symptoms of stomatitis. Start date of the first occurrence of stomatitis is defined as the first date ever recorded for this item in the questionnaire. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | From first study treatment administration in the first line until first stomatitis episode, assessed up to approximately 3.8 years |
| First-line Treatment (Stomatitis Sub-study): Duration of First Stomatitis Based on OSDQ | The duration of the first stomatitis was calculated using the start and end date reported in the OSDQ. The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis. The first item asked the participants the date when they experienced the first symptoms of stomatitis. Start date of the first stomatitis is defined as the first date ever recorded for this item in the questionnaire. Stop date of the first stomatitis is defined as the last date the OSDQ was completed for this episode. Participants were censored if they died before resolution of stomatitis, received a new anticancer therapy, discontinued the study treatment with no resolution of the stomatitis or the stomatitis was still on-going at the cut-off. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
| First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Overall Health at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The second item asked the participant to rate their overall health from 0 (worst possible) to 10 (perfect health). The overall health OSDQ score are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
| First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The third item asked the participant to rate their mouth and throat soreness from 0 (no soreness) to 4 (extreme soreness). The mouth and throat soreness OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | From start date of stomatitis episode until its resolution, assessed up to 3.8 years |
| First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness Limiting Swallowing, Drinking, Eating, Talking and Sleeping at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The fourth item asked the participant to rate how much their mouth and throat soreness limited them in 1) swallowing, 2) drinking, 3) eating, 4) talking and 5) sleeping. For each activity, mouth and throat soreness scores ranged from 0 (not limited) to 4 (unable to do). Scores are presented as the shift from Day 1 of first stomatitis stomatitis value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first episode value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
| First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The fifth item asked the participant to rate their mouth pain severity from 0 (no pain) to 10 (unbearable pain). The mouth pain severity OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
| First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity Affecting Daily Activities at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The sixth item asked the participant to rate their mouth pain severity affecting daily activities score from 0 (no effect on daily activities) to 10 (completely prevented from doing daily activities). The mouth pain severity affecting daily activities OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
| Number of Participants With Clinical Benfit During Extension Phase | Number of participants with clinical benefit as judged by the investigator during the extension phase. The extension phase for up to 3 years for participants who were continuing to benefit from study treatment following the end of the core study phase (24 months after last patient's recruitment) was added in the amendment 5 (dated 14-Feb-2017). Results are presented by line of treatment | From the end of core phase (upon approval of amendment 5) up to approximately 3 years |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Loma Linda University Loma Linda | Loma Linda | California | 92354 | United States |
| Breastlink Medical Group Dept. of BreastlinkResearchGrp | Long Beach | California | 90806 | United States |
| Oncology Specialists, SC Advocate Medical Group-Niles | Park Ridge | Illinois | 60068-0736 | United States |
| St. Francis Health Comprehensive Cancer Center | Topeka | Kansas | 66606-169 | United States |
| Norton Healthcare Inc SC | Louisville | Kentucky | 40202 | United States |
| Baystate Medical Center SC-2 | Springfield | Massachusetts | 01199 | United States |
| Saint Barnabas Medical Center CancerCenter of Saint Barnabas | Livingston | New Jersey | 07039 | United States |
| University of New Mexico Hospital SC | Albuquerque | New Mexico | 87106 | United States |
| Broome Oncology SC | Johnson City | New York | 13790 | United States |
| Columbia University Medical Center- New York Presbyterian Columbia | New York | New York | 10032 | United States |
| Cone Health Cancer Center | Greensboro | North Carolina | 27403 | United States |
| East Texas Hematology Clinic SC | Lufkin | Texas | 75904 | United States |
| Utah Cancer Specialists Dept.of Utah Cancer Spec. (3) | Salt Lake City | Utah | 84106 | United States |
| Novartis Investigative Site | Santa Rosa | La Pampa Province | 6300 | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01317-002 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04014-002 | Brazil |
| Novartis Investigative Site | Besançon | 25030 | France |
| Novartis Investigative Site | Bordeaux | 33076 | France |
| Novartis Investigative Site | Hyères | 83400 | France |
| Novartis Investigative Site | Le Chesnay | 78157 | France |
| Novartis Investigative Site | Lyon | 69373 | France |
| Novartis Investigative Site | Nancy | 54000 | France |
| Novartis Investigative Site | Nantes | 44277 | France |
| Novartis Investigative Site | Kecskemét | Bács-Kiskun county | 6000 | Hungary |
| Novartis Investigative Site | Gyula | 5700 | Hungary |
| Novartis Investigative Site | Szekszárd | 7100 | Hungary |
| Novartis Investigative Site | Nagoya | Aichi-ken | 467-8602 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 003-0804 | Japan |
| Novartis Investigative Site | Shiwa-gun | Iwate | 028-3695 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 216-8511 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 860-8556 | Japan |
| Novartis Investigative Site | Maastricht | AZ | 5800 | Netherlands |
| Novartis Investigative Site | Lisbon | 1400-038 | Portugal |
| Novartis Investigative Site | Lisbon | 1649-035 | Portugal |
| Novartis Investigative Site | Porto | 4200-072 | Portugal |
| Novartis Investigative Site | Seoul | 01812 | South Korea |
| Novartis Investigative Site | Seoul | 06273 | South Korea |
| Novartis Investigative Site | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Salamanca | Castille and León | 37007 | Spain |
| Novartis Investigative Site | A Coruña | Galicia | 15006 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46010 | Spain |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Antalya | 07059 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34303 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | Bath | BA1 3NG | United Kingdom |
| Dexamethasone Randomized Set (Stomatitis Sub-study) | Participants experiencing stomatitis (in countries where the alcohol-free 0.5 mg/5 mL dexamethasone oral solution was commercially available) randomized to take 0.5 mg/5 mL dexamethasone mouth rinse. |
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| Standard of Care Randomized Set (Stomatitis Sub-study) | Participants experiencing stomatitis (in countries where the alcohol-free 0.5 mg/5 mL dexamethasone oral solution was commercially available) randomized to take standard of care to treat stomatitis |
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| COMPLETED |
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| NOT COMPLETED |
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| Second Line Treatment (Core+Extension) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus+Letrozole/Exemestane (First-line Treatment and Second-line Treatment) | Participants received everolimus in combination with letrozole as first line treatment. Only participants who had disease progression in the first line setting (core phase) were offered second-line treatment (everolimus in combination with exemestane) |
| Units | Counts |
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| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | ||||||||||||||||||||
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| Primary | First-line Treatment: Progression-free Survival (PFS) | PFS in the first line setting is defined as the time from the date of enrollment to the date of first documented progression based on local radiology review or death due to any cause. If a participant did not progress or was not known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. The median PFS was estimated and presented along with 95% confidence intervals. The primary analysis of PFS for first line was performed 12 months after the last patient's recruitment. | Full Analysis Set (FAS): All participants to whom the first-line study treatment was assigned | Posted | Median | 95% Confidence Interval | Months | From the date of enrollment to the date of first documented progression or deaths, assessed up to approximately 2.8 years |
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| Secondary | First-line Treatment: Overall Response Rate (ORR) | ORR in first line setting is defined as the percentage of participants while on first-line treatment with best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.0 based on local review. Confidence intervals were calculated based on the Exact Clopper-Pearson method. ORR while on first-line treatment was assessed up to 24 months after the last patient's recruitment. CR: disappearance of all target lesions PR: at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. | FAS: All participants to whom the first-line study treatment was assigned | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of enrollment until discontinuation of first-line treatment, assessed up to approximately 3.8 years |
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| Secondary | First-line Treatment: Clinical Benefit Rate (CBR) | CBR in first line is defined as the percentage of participants while on first-line treatment with best overall response of CR, PR or stable disease (SD) with a duration of 24 weeks or longer, according to RECIST version 1.0 based on local review. Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. CBR while on first-line treatment was assessed up to 24 months after the last patient's recruitment. CR: disappearance of all target lesions PR: at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease | FAS: All participants to whom the first-line study treatment was assigned | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of enrollment until first-line treatment discontinuation, assessed up to approximately 3.8 years |
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| Secondary | Second-line Treatment: Progression-free Survival (PFS) | PFS in the second line setting is defined as the time interval between the start of the second-line treatment and documented disease progression based on local radiology review or death due to any cause reported during or after second-line treatment period. If a participant did not progress or was not known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. The median PFS was estimated and presented along with 95% confidence intervals. PFS while on second-line treatment was assessed up to 24 months after the last patient's recruitment. | Participants in the Full Analysis Set second line (FAS-2L), including all participants in the FAS who received at least one dose of second-line study medication, with evaluable data for this endpoint. | Posted | Median | 95% Confidence Interval | Months | From the start of the second-line treatment until the date of first documented progression or death, assessed up to approximately 2.4 years |
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| Secondary | Second-line Treatment: Overall Response Rate (ORR) | ORR in second line is defined as the percentage of participants receiving second-line study treatment with best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.0 based on local review. Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. ORR while on second-line treatment was assessed up to 24 months after the last patient's recruitment. CR: disappearance of all target lesions PR: at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters | Participants in the FAS-2L, including all participants in the FAS who received at least one dose of second-line study medication, with evaluable data for this endpoint | Posted | Number | 95% Confidence Interval | Percentage of participants | From the start of the second-line treatment up to approximately 2.4 years |
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| Secondary | Second-line Treatment: Clinical Benefit Rate (CBR) | CBR in second line is defined as the percentage of participants receiving second-line study treatment with best overall response of CR, PR or stable disease (SD) with a duration of 24 weeks or longer, according to RECIST version 1.0 based on local review. Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. CBR while on second-line treatment was assessed up to 24 months after the last patient's recruitment. CR: disappearance of all target lesions PR: at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease | Participants in the FAS-2L, including all participants in the FAS who received at least one dose of second-line study medication, with evaluable data for this endpoint | Posted | Number | 95% Confidence Interval | Percentage of participants | From the start of the second-line treatment up to approximately 2.4 years |
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| Secondary | Overall Survival (OS) | OS following first-line treatment with everolimus + letrozole is defined as the time from the date of receiving first line study treatment to date of death due to any cause (including first-line and second-line treatment periods). If a participant was not known to have died, survival was censored at the date of last contact. OS following first-line treatment was assessed up to 24 months after last patient's recruitment. | FAS: All participants to whom the first-line study treatment was assigned | Posted | Median | 95% Confidence Interval | Months | From the date of enrollment to date of death, assessed up to approximately 3.8 years |
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| Secondary | First-line Treatment: Time to First Stomatitis Episode as Assessed by the Oral Stomatitis Daily Questionnaire (OSDQ) | The time to first occurrence of stomatitis based on OSDQ is defined as time from first-line treatment administration to start date of the stomatitis episode recorded in the OSDQ in the first line. The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The first item asked the participants when they experienced the first symptoms of stomatitis. Start date of the first occurrence of stomatitis is defined as the first date ever recorded for this item in the questionnaire. Patient reported outcomes (PROs) were assessed up to 24 months after last patient's recruitment. | First-line stomatitis analysis set (SAS-1L): All participants in the FAS who agreed to fill in the OSDQ and who developed their first stomatitis event (based on OSDQ) in the first line. | Posted | Median | 95% Confidence Interval | Weeks | From first-line treatment administration until first stomatitis episode in the first line, assessed up to approximately 3.8 years |
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| Secondary | First-line Treatment: Duration of First Stomatitis Based on OSDQ | The duration of the first stomatitis episode was calculated using the start and end date recorded in the OSDQ. The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis. The first item of the questionnaire asked the participants the date when they experienced the first symptoms of stomatitis. Start date of the first occurrence of stomatitis is defined as the first date ever recorded for this item in the questionnaire. Stop date of the first stomatitis episode is defined as the last date the OSDQ was completed for this episode. Participants were censored if they died before resolution of stomatitis, received a new anticancer therapy, discontinued the study treatment with no resolution of the stomatitis or the stomatitis event was still on-going at the cut-off. PROs were assessed up to 24 months after last patient's recruitment. | First-line stomatitis analysis set (SAS-1L): All participants in the FAS who agreed to fill in the OSDQ and who developed their first stomatitis event (based on OSDQ) in the first line. | Posted | Median | 95% Confidence Interval | Weeks | From start date of first stomatitis episode in first line until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Overall Health at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily up to the resolution of the stomatitis episode. The second item asked the participant to rate their overall health from 0 (worst possible) to 10 (perfect health). The overall health OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. | First-line stomatitis analysis set (SAS-1L): All participants in the FAS who agreed to fill in the OSDQ and who developed their first stomatitis event (based on OSDQ) in the first line. | Posted | Count of Participants | Participants | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The third item asked the participant to rate their mouth and throat soreness from 0 (no soreness) to 4 (extreme soreness). The mouth and throat soreness OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. | First-line stomatitis analysis set (SAS-1L): All participants in the FAS who agreed to fill in the OSDQ and who developed their first stomatitis event (based on OSDQ) in the first line. | Posted | Count of Participants | Participants | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness Limiting Swallowing, Drinking, Eating, Talking and Sleeping at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The fourth item asked the participant to rate how much their mouth and throat soreness limited them in 1) swallowing, 2) drinking, 3) eating, 4) talking and 5) sleeping. For each activity, mouth and throat soreness scores ranged from 0 (not limited) to 4 (unable to do). Scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. | First-line stomatitis analysis set (SAS-1L): All participants in the FAS who agreed to fill in the OSDQ and who developed their first stomatitis event (based on OSDQ) in the first line. | Posted | Count of Participants | Participants | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The fifth item asked the participant to rate their mouth pain severity from 0 (no pain) to 10 (unbearable pain). The mouth pain severity OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. | First-line stomatitis analysis set (SAS-1L): All participants in the FAS who agreed to fill in the OSDQ and who developed their first stomatitis event (based on OSDQ) in the first line. | Posted | Count of Participants | Participants | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity Affecting Daily Activities at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The sixth item asked the participant to rate their mouth pain severity affecting daily activities score from 0 (no effect on daily activities) to 10 (completely prevented from doing daily activities). The mouth pain severity affecting daily activities OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. | First-line stomatitis analysis set (SAS-1L): All participants in the FAS who agreed to fill in the OSDQ and who developed their first stomatitis event (based on OSDQ) in the first line. | Posted | Count of Participants | Participants | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment (Stomatitis Sub-study): Time to First Stomatitis Episode as Assessed by the OSDQ | The time to first occurrence of stomatitis based on OSDQ is defined as time from first study treatment administration in the first line to start date of the first stomatitis episode recorded in the OSDQ. The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The first item asked the participants when they experienced the first symptoms of stomatitis. Start date of the first occurrence of stomatitis is defined as the first date ever recorded for this item in the questionnaire. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | Stomatitis randomized set: All participants in the FAS who were randomized in the stomatitis sub-study to receive dexamethasone or standard of care (i.e. participants in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution was commercially available who experienced a stomatitis event). Number analyzed indicates the number of participants randomized to each intervention | Posted | Median | 95% Confidence Interval | Weeks | From first study treatment administration in the first line until first stomatitis episode, assessed up to approximately 3.8 years |
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| Secondary | First-line Treatment (Stomatitis Sub-study): Duration of First Stomatitis Based on OSDQ | The duration of the first stomatitis was calculated using the start and end date reported in the OSDQ. The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis. The first item asked the participants the date when they experienced the first symptoms of stomatitis. Start date of the first stomatitis is defined as the first date ever recorded for this item in the questionnaire. Stop date of the first stomatitis is defined as the last date the OSDQ was completed for this episode. Participants were censored if they died before resolution of stomatitis, received a new anticancer therapy, discontinued the study treatment with no resolution of the stomatitis or the stomatitis was still on-going at the cut-off. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | Stomatitis randomized set: All participants in the FAS who were randomized in the stomatitis sub-study to receive dexamethasone or standard of care (i.e. participants in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution was commercially available who experienced a stomatitis event). Number analyzed indicates the number of participants randomized to each intervention | Posted | Median | 95% Confidence Interval | Weeks | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Overall Health at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The second item asked the participant to rate their overall health from 0 (worst possible) to 10 (perfect health). The overall health OSDQ score are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | Stomatitis randomized set: All participants in the FAS who were randomized in the stomatitis sub-study to receive dexamethasone or standard of care (i.e. participants in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution was commercially available who experienced a stomatitis event). Number analyzed indicates the number of participants randomized to each intervention | Posted | Count of Participants | Participants | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The third item asked the participant to rate their mouth and throat soreness from 0 (no soreness) to 4 (extreme soreness). The mouth and throat soreness OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | Stomatitis randomized set: All participants in the FAS who were randomized in the stomatitis sub-study to receive dexamethasone or standard of care (i.e. participants in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution was commercially available who experienced a stomatitis event). Number analyzed indicates the number of participants randomized to each intervention. | Posted | Count of Participants | Participants | From start date of stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness Limiting Swallowing, Drinking, Eating, Talking and Sleeping at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The fourth item asked the participant to rate how much their mouth and throat soreness limited them in 1) swallowing, 2) drinking, 3) eating, 4) talking and 5) sleeping. For each activity, mouth and throat soreness scores ranged from 0 (not limited) to 4 (unable to do). Scores are presented as the shift from Day 1 of first stomatitis stomatitis value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first episode value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | Stomatitis randomized set: All participants in the FAS who were randomized in the stomatitis sub-study to receive dexamethasone or standard of care (i.e. participants in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution was commercially available who experienced a stomatitis event). Number analyzed indicates the number of participants randomized to each intervention | Posted | Count of Participants | Participants | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The fifth item asked the participant to rate their mouth pain severity from 0 (no pain) to 10 (unbearable pain). The mouth pain severity OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | Stomatitis randomized set: All participants in the FAS who were randomized in the stomatitis sub-study to receive dexamethasone or standard of care (i.e. participants in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution was commercially available who experienced a stomatitis event). Number analyzed indicates the number of participants randomized to each intervention | Posted | Count of Participants | Participants | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity Affecting Daily Activities at the End of the First Stomatitis Episode | The OSDQ is a patient self-administered 6-item questionnaire with a 24-hour recall period. Participants completed the questionnaire daily until the resolution of the stomatitis episode. The sixth item asked the participant to rate their mouth pain severity affecting daily activities score from 0 (no effect on daily activities) to 10 (completely prevented from doing daily activities). The mouth pain severity affecting daily activities OSDQ scores are presented as the shift from Day 1 of first stomatitis episode value to the value at the end of the first episode of stomatitis. Day 1 is defined as the first OSDQ questionnaire recorded. End of first stomatitis value is defined as the last OSDQ questionnaire of the first episode of stomatitis. PROs were assessed up to 24 months after last patient's recruitment. Only participants who were randomized in the stomatitis sub-study were included in this analysis. | Stomatitis randomized set: All participants in the FAS who were randomized in the stomatitis sub-study to receive dexamethasone or standard of care (i.e. participants in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution was commercially available who experienced a stomatitis event). Number analyzed indicates the number of participants randomized to each intervention | Posted | Count of Participants | Participants | From start date of first stomatitis episode until its resolution, assessed up to 3.8 years |
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| Secondary | Number of Participants With Clinical Benfit During Extension Phase | Number of participants with clinical benefit as judged by the investigator during the extension phase. The extension phase for up to 3 years for participants who were continuing to benefit from study treatment following the end of the core study phase (24 months after last patient's recruitment) was added in the amendment 5 (dated 14-Feb-2017). Results are presented by line of treatment | For first-line treatment, all participants to whom the first-line treatment was assigned (FAS) For second-line treatment, all participants in the FAS who received at least one dose of second-line study medication (FAS-2L) | Posted | Count of Participants | Participants | From the end of core phase (upon approval of amendment 5) up to approximately 3 years |
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| Post-Hoc | All Collected Deaths | On-treatment deaths in first line were collected from first dose of first-line treatment until the date of last administration of the first-line study treatment plus 28 days for participants not entering second-line or the minimum between the date of last administration of the first-line study treatment plus 28 days and the date of first administration of second-line study treatment minus one day for participants entering second line, up to 7.3 years. On-treatment deaths in second line were collected from first dose of second-line treatment to 28 days after the last administration of second-line treatment, up to 5.4 years. Post-treatment survival follow-up deaths were collected from day 29 after last dose of study treatment to end of study, up to 7.3 years. All deaths refer to the sum of on-treatment deaths and post-treatment deaths. | All participants who received at least one dose of study medication and had at least one post-baseline safety assessment. The safety analysis for the second line was performed on the subset of participants receiving at least one dose of second-line medication. | Posted | Number | Participants | On-treatment deaths in first line: Up to 7.3 years. On-treatment deaths in second line: Up to 5.4 years. Post-treatment and all deaths: Up to 7.3 years |
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First-line on-treatment: from the first first-line dose to 28 days post first-line treatment (or 1 day before second-line dose, whichever was earlier, for participants receiving second-line), up to 7.3 years. Second-line on-treatment: from first second-line dose to 28 days post second-line treatment, up to 5.4 years. Post-treatment deaths: from day 29 after final dose to end of study, up to 7.3 years.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
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 | Everolimus+Letrozole (First-line on Treatment) | AEs during first-line on-treatment period were collected from the initial first-line dose to 28 days after the last first-line dose, for participants without second-line. For those with second-line treatment, the period lasts until the minimum of 28 days after the last first-line dose or one day before second-line treatment administration. | 11 | 202 | 72 | 202 | 202 | 202 |
| EG001 | Everolimus+Exemestane (Second-line On-treatment) | AEs during second-line on-treatment period were collected from first second-line dose to 28 days post second-line treatment | 2 | 53 | 8 | 53 | 43 | 53 |
| EG002 | Everolimus+Letrozole/Exemestane (Post-treatment Survival Follow-up) | Deaths collected in the post- treatment survival follow-up period (starting from day 29 after last dose of study treatment). No AEs were collected during this period | 49 | 125 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
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| Bicytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Pupils unequal | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Femoral hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatitis viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Vulvitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Snake bite | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urogenital prolapse | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
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 | Jun 21, 2018 | Jan 12, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000077289 | Letrozole |
| C056516 | exemestane |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000438 | Alcohols |
Not provided
Not provided
| Disease progression |
|
| Physician Decision |
|
| Asian |
|
| Pacific islander |
|
| Other |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
Participants received everolimus in combination with letrozole as first-line treatment. |
|
|
|
|
Participants received everolimus in combination with letrozole as first-line treatment.
|
|
| Counts |
|---|
| Participants |
|
|
|
|