| ID | Type | Description | Link |
|---|---|---|---|
| CLAP016A2308 | Other Identifier | Novartis | |
| 2004-003928-35 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.
Subjects were randomly assigned to receive either lapatinib (1500 mg once daily orally) with letrozole (2.5 mg once daily orally), or letrozole (2.5 mg once daily orally) with placebo (which matched with lapatinib tablet). Randomization was stratified by site of disease (i.e., soft tissue/visceral disease versus bone only disease) and time since prior adjuvant endocrine therapy (<6 months or ≥ 6 months from discontinuation of adjuvant anti-estrogen therapy (e.g. tamoxifen or raloxifene) or no prior adjuvant antiestrogen therapy). Study therapy was administered daily until disease progression (objective or symptomatic) or withdrawal from therapy (e.g., due to unacceptable toxicity, withdrawal of consent, or other reason). All subjects were to be followed for survival information until death.
On 13 Apr 2015, after the introduction of the Long Term Follow UP (LTFU) phase (per protocol amendment 07), subjects receiving study treatment with lapatinib plus letrozole, or letrozole plus placebo had continued access to this study treatment until the occurrence of one of the following criteria:
The study was terminated on 22-Mar-2018 (last subject last visit).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Letrozole 2.5 mg | Placebo Comparator | Letrozole (2.5 mg once daily orally) with Placebo (which matched with Lapatinib tablet) |
|
| Lapatinib 1500 mg + Letrozole 2.5 mg | Experimental | Lapatinib (1500 mg once daily orally) with Letrozole (2.5 mg once daily orally) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lapatinib | Drug | 1500 mg orally once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator | PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. | From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months |
| Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator | PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator | PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. |
Not provided
Key inclusion criteria
Signed informed consent;
Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;
Tumors that were ER+ and/or PgR+;
Post-menopausal female subjects ≥ 18 years of age.
ECOG Performance Status of 0 or 1;
Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.
Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (>12 months) to the first dose of randomized therapy.
Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.
Key exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Tucson | Arizona | 85715 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19786658 | Background | Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28. | |
| 20156908 |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
This study was conducted at 212 centers in 29 countries (Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Republic of Korea, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Russian Federation, South-Africa, Spain, Tunisia, Turkey, UK, USA).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Letrozole 2.5 mg | Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Letrozole | Drug | 2.5 mg orally once a day |
|
| Placebo | Drug | Placebo (which matched with lapatinib tablet) |
|
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months |
| PFS in Participants in the ITT Population as Assessed by the Investigator | PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months |
| Overall Survival in the HER2-Positive Population | Overall survival was defined as the time from randomization until death due to any cause. | From date of randomization until date of death due to any cause, assessed up to 46 months |
| Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator | OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. | Up to 46 months |
| Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator | Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT to the randomization date. | Up to 46 months |
| Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator | CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement. | Up to 46 months |
| Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator. | CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions. | Up to 46 months |
| Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator. | CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions. | Up to 46 months |
| Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator | Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans. | Up to 46 months |
| Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator | Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans. | Up to 46 months |
| Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population | The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another. | Up to 46 months |
| Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator | TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator. | Up to 46 months |
| Overall Survival in the ITT Population | Overall survival was defined as the time from randomization until death due to any cause. | From date of randomization until date of death due to any cause, assessed up to 46 months |
| Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator | OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. | Up to 46 months |
| Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator | Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT and the randomization date. | Up to 46 months |
| Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator | CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement. | Up to 46 months |
| Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator | Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans. | Up to 46 months |
| Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator | Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans. | Up to 46 months |
| Number of Participants With Evidence of Brain Metastases From the ITT Population | The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another. | Up to 46 months |
| TTP for Participants From the ITT Population as Assessed by the Investigator | TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator. | Up to 46 months |
| Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits | Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales (each ranging from 0 [not at all] to 4 [very much]) indicate a higher QOL. The score is transformed for FACT-B and results in a total score ranging from 0 to 144. Complete: completing at least 1 question from FACT-B. | Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit |
| Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data | Quality of Life (QOL) was assessed using the FACT-B questionnaire, which is a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144. The FACT-B is designed to measure multidimensional QOL in participants with breast cancer. | Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit |
| Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data | FACT-G is a subscale of the FACT-B QOL questionnaire and consists of 27 questions grouped into 4 domains that measure a participant's physical, functional, social and family, and emotional well-being. FACT-G is assessed on a five-point Likert-type scale, with scores ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total score is calculated as the sum of the item scores on the subscale; the total ranges from 0 to 108, with higher score indicating a better quality of life. | Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit |
| Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data | The TOI score is the sum of the physical well-being, functional well-being, and breast cancer unweighted subscale scores. The total TOI score ranges from 0 to 92, with higher scores representing a better quality of life. | Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit |
| Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores | A minimally important difference (MID) is the smallest difference in a score for a measure of QOL that corresponds to a difference in function or clinical course. Responders are defined as participants with an MID => 8 for the FACT-B score, and an MID =>6 for the FACT-G and TOI scores. | Up to 46 months |
| Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status | Clinical benefit: participants with CR, PR, or SD for =>6-month period. FISH testing measures the amount of the HER2 gene in each cell. This gene is responsible for the overproduction of the HER2 protein. FISH-positive: excessive amounts of the gene are present; FISH-negative: normal levels of the gene are present. | Up to 46 months |
| Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity | IHC is a commonly used test to assess the amount of the HER2 receptor protein on the surface of the cancer cells. The IHC test results in a score of 0 to 3+, which indicates the amount of HER2 receptor protein on the cells in a sample of breast cancer tissue. Tissue scores of 0 to 1+ indicate HER2 negativity; scores of 2+ and 3+ indicate HER2 positivity. Clinical benefit is defined as participants with CR, PR, or SD for =>6-month period. | Up to 46 months |
| Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower | The HER2 ECD is a glycoprotein that can be shed from the cell surface into the blood of normal individuals and can be elevated in different pathologic conditions. The serum HER2 ECD level generally reflects the tissue HER2 status. The HER2 ECD is quantified in serum with an enzyme-linked immunosorbent assay (ELISA). Non-Evaluable (NE): any participant who could not be classified as CR, PR, SD, or PD. | Up to 46 months |
| Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive | Participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL experienced seroconversion. | Up to 46 months |
| Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive | Time to seroconversion was defined as the time from the date of randomization until the first instance of serum HER2 (>15 ng/mL) on two consecutive occasions. | Up to 46 months |
| Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline | EGFR is a cell surface receptor tyrosine kinase expressed in certain types of tumors. Depending upon the staining intensity, EGFR was graded as follows: 0=absence of membrane staining above background in all tumor cells; EGFR-positive=staining is defined as any IHC staining of tumor cell membranes above background level, whether it is complete or incomplete circumferential staining (1+, 2+, 3+). | Baseline |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Novartis Investigative Site | Jonesboro | Arkansas | 72401 | United States |
| Novartis Investigative Site | Alhambra | California | 91801 | United States |
| Novartis Investigative Site | Bakersfield | California | 93309 | United States |
| Novartis Investigative Site | Duarte | California | 91010 | United States |
| Novartis Investigative Site | Fountain Valley | California | 92708 | United States |
| Novartis Investigative Site | Fresno | California | 93710 | United States |
| Novartis Investigative Site | Fullerton | California | 92835 | United States |
| Novartis Investigative Site | La Jolla | California | 92093-0987 | United States |
| Novartis Investigative Site | Long Beach | California | 90813 | United States |
| Novartis Investigative Site | Los Angeles | California | 90095 | United States |
| Novartis Investigative Site | Montebello | California | 90640 | United States |
| Novartis Investigative Site | Northridge | California | 91325 | United States |
| Novartis Investigative Site | Oxnard | California | 93030 | United States |
| Novartis Investigative Site | Pleasant Hill | California | 94523 | United States |
| Novartis Investigative Site | Porterville | California | 93257 | United States |
| Novartis Investigative Site | Redondo Beach | California | 90277 | United States |
| Novartis Investigative Site | San Diego | California | 92120 | United States |
| Novartis Investigative Site | Santa Barbara | California | 93105 | United States |
| Novartis Investigative Site | Santa Maria | California | 93454 | United States |
| Novartis Investigative Site | Vallejo | California | 94589 | United States |
| Novartis Investigative Site | Vista | California | 92081 | United States |
| Novartis Investigative Site | Aurora | Colorado | 80045 | United States |
| Novartis Investigative Site | Denver | Colorado | 80220 | United States |
| Novartis Investigative Site | Longmont | Colorado | 80501 | United States |
| Novartis Investigative Site | Wheat Ridge | Colorado | 80033 | United States |
| Novartis Investigative Site | New Haven | Connecticut | 06520 | United States |
| Novartis Investigative Site | Boca Raton | Florida | 33428 | United States |
| Novartis Investigative Site | Boca Raton | Florida | 33486 | United States |
| Novartis Investigative Site | Gainesville | Florida | 32605 | United States |
| Novartis Investigative Site | Gainesville | Florida | 32610 | United States |
| Novartis Investigative Site | Hollywood | Florida | 33021 | United States |
| Novartis Investigative Site | Lakeland | Florida | 33805 | United States |
| Novartis Investigative Site | Miami | Florida | 33136 | United States |
| Novartis Investigative Site | Orlando | Florida | 32804 | United States |
| Novartis Investigative Site | Port Saint Lucie | Florida | 34952 | United States |
| Novartis Investigative Site | West Palm Beach | Florida | 33401 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30341 | United States |
| Novartis Investigative Site | Marietta | Georgia | 30060 | United States |
| Novartis Investigative Site | Savannah | Georgia | 31406 | United States |
| Novartis Investigative Site | Peoria | Illinois | 61615 | United States |
| Novartis Investigative Site | Skokie | Illinois | 60076 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46202 | United States |
| Novartis Investigative Site | Bettendorf | Iowa | 52722 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40202 | United States |
| Novartis Investigative Site | Metairie | Louisiana | 70006 | United States |
| Novartis Investigative Site | New Orleans | Louisiana | 70121 | United States |
| Novartis Investigative Site | Worcester | Massachusetts | 01608 | United States |
| Novartis Investigative Site | Duluth | Minnesota | 55805 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55407-3799 | United States |
| Novartis Investigative Site | Robbinsdale | Minnesota | 55422 | United States |
| Novartis Investigative Site | Saint Louis Park | Minnesota | 55426 | United States |
| Novartis Investigative Site | Saint Charles | Missouri | 63304 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63141 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68114 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89169 | United States |
| Novartis Investigative Site | Voorhees Township | New Jersey | 08043 | United States |
| Novartis Investigative Site | Santa Fe | New Mexico | 87505 | United States |
| Novartis Investigative Site | Manhasset | New York | 11030 | United States |
| Novartis Investigative Site | Rochester | New York | 14623 | United States |
| Novartis Investigative Site | Chapel Hill | North Carolina | 27599-7305 | United States |
| Novartis Investigative Site | Greenville | North Carolina | 27834 | United States |
| Novartis Investigative Site | Fargo | North Dakota | 58103 | United States |
| Novartis Investigative Site | Canton | Ohio | 44718 | United States |
| Novartis Investigative Site | Hershey | Pennsylvania | 17033 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19111 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Novartis Investigative Site | West Columbia | South Carolina | 29210 | United States |
| Novartis Investigative Site | Germantown | Tennessee | 38138 | United States |
| Novartis Investigative Site | Knoxville | Tennessee | 37916 | United States |
| Novartis Investigative Site | Amarillo | Texas | 79106 | United States |
| Novartis Investigative Site | Dallas | Texas | 75246 | United States |
| Novartis Investigative Site | Dallas | Texas | 75390-9113 | United States |
| Novartis Investigative Site | Houston | Texas | 77025 | United States |
| Novartis Investigative Site | Irving | Texas | 75061 | United States |
| Novartis Investigative Site | Ogden | Utah | 84403 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84106 | United States |
| Novartis Investigative Site | Burlington | Vermont | 05401 | United States |
| Novartis Investigative Site | Danville | Virginia | 24541 | United States |
| Novartis Investigative Site | Richmond | Virginia | 23230 | United States |
| Novartis Investigative Site | Seattle | Washington | 98104 | United States |
| Novartis Investigative Site | Tacoma | Washington | 98405 | United States |
| Novartis Investigative Site | Charleston | West Virginia | 25304 | United States |
| Novartis Investigative Site | Capital Federal | Buenos Aires | C1426ANZ | Argentina |
| Novartis Investigative Site | Buenos Aires | 1425 | Argentina |
| Novartis Investigative Site | Buenos Aires | C1405BWU | Argentina |
| Novartis Investigative Site | Garran | Australian Capital Territory | 2606 | Australia |
| Novartis Investigative Site | Douglas | Queensland | 4814 | Australia |
| Novartis Investigative Site | Herston | Queensland | 4029 | Australia |
| Novartis Investigative Site | Redcliffe | Queensland | 4020 | Australia |
| Novartis Investigative Site | Adelaide | South Australia | 5000 | Australia |
| Novartis Investigative Site | Salvador | Estado de Bahia | 41825-010 | Brazil |
| Novartis Investigative Site | Rio de Janeiro | 20560-120 | Brazil |
| Novartis Investigative Site | Plovdiv | 4000 | Bulgaria |
| Novartis Investigative Site | Sofia | 1527 | Bulgaria |
| Novartis Investigative Site | Sofia | 1756 | Bulgaria |
| Novartis Investigative Site | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Novartis Investigative Site | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Novartis Investigative Site | London | Ontario | N6A 4L6 | Canada |
| Novartis Investigative Site | Mississauga | Ontario | L5B 1B8 | Canada |
| Novartis Investigative Site | Oshawa | Ontario | L1G 2B9 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M6R 1B5 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H1T 2M4 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2L 4M1 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3T 1E2 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H4J 1C5 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1S 4L8 | Canada |
| Novartis Investigative Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Novartis Investigative Site | Santiago | Región Metro de Santiago | 7500921 | Chile |
| Novartis Investigative Site | Santiago | Región Metro de Santiago | 7591046 | Chile |
| Novartis Investigative Site | Bogotá | Colombia |
| Novartis Investigative Site | Osijek | 31000 | Croatia |
| Novartis Investigative Site | Pula | 52100 | Croatia |
| Novartis Investigative Site | Split | 21000 | Croatia |
| Novartis Investigative Site | Brno | 656 53 | Czechia |
| Novartis Investigative Site | České Budějovice | 370 87 | Czechia |
| Novartis Investigative Site | Prague | 180 00 | Czechia |
| Novartis Investigative Site | Aalborg | 9000 | Denmark |
| Novartis Investigative Site | Hillerød | 3400 | Denmark |
| Novartis Investigative Site | Koebenhavn Oe | 2100 | Denmark |
| Novartis Investigative Site | Næstved | 4700 | Denmark |
| Novartis Investigative Site | Odense C | 5000 | Denmark |
| Novartis Investigative Site | Roskilde | 4000 | Denmark |
| Novartis Investigative Site | Vejle | 7100 | Denmark |
| Novartis Investigative Site | Angers | 49033 | France |
| Novartis Investigative Site | Besançon | 25030 | France |
| Novartis Investigative Site | Grenoble | 38043 | France |
| Novartis Investigative Site | Lille | 59020 | France |
| Novartis Investigative Site | Montpellier | 34298 | France |
| Novartis Investigative Site | Paris | 75248 | France |
| Novartis Investigative Site | Pierre-Bénite | 69495 | France |
| Novartis Investigative Site | Toulouse Cedex9 | 31059 | France |
| Novartis Investigative Site | Villejuif | 94805 | France |
| Novartis Investigative Site | Aalen | Baden-Wurttemberg | 73428 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Novartis Investigative Site | Heidelberg | Baden-Wurttemberg | 69115 | Germany |
| Novartis Investigative Site | Heidenheim | Baden-Wurttemberg | 89518 | Germany |
| Novartis Investigative Site | Schwetzingen | Baden-Wurttemberg | 68723 | Germany |
| Novartis Investigative Site | Stuttgart | Baden-Wurttemberg | 70174 | Germany |
| Novartis Investigative Site | Ulm | Baden-Wurttemberg | 89075 | Germany |
| Novartis Investigative Site | Augsburg | Bavaria | 86150 | Germany |
| Novartis Investigative Site | Bayreuth | Bavaria | 95445 | Germany |
| Novartis Investigative Site | Erlangen | Bavaria | 91054 | Germany |
| Novartis Investigative Site | Munich | Bavaria | 80335 | Germany |
| Novartis Investigative Site | Munich | Bavaria | 80637 | Germany |
| Novartis Investigative Site | Munich | Bavaria | 81377 | Germany |
| Novartis Investigative Site | Regensburg | Bavaria | 93049 | Germany |
| Novartis Investigative Site | Rehling | Bavaria | 86508 | Germany |
| Novartis Investigative Site | Rosenheim | Bavaria | 83002 | Germany |
| Novartis Investigative Site | Frankfurt am Main | Hesse | 60590 | Germany |
| Novartis Investigative Site | Frankfurt am Main | Hesse | 60596 | Germany |
| Novartis Investigative Site | Wiesbaden | Hesse | 65191 | Germany |
| Novartis Investigative Site | Wiesbaden | Hesse | 65199 | Germany |
| Novartis Investigative Site | Goslar | Lower Saxony | 38642 | Germany |
| Novartis Investigative Site | Leer | Lower Saxony | 26789 | Germany |
| Novartis Investigative Site | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Novartis Investigative Site | Coesfeld | North Rhine-Westphalia | 48653 | Germany |
| Novartis Investigative Site | Düsseldorf | North Rhine-Westphalia | 40217 | Germany |
| Novartis Investigative Site | Ibbenbueren | North Rhine-Westphalia | 49477 | Germany |
| Novartis Investigative Site | Münster | North Rhine-Westphalia | 48149 | Germany |
| Novartis Investigative Site | Troisdorf | North Rhine-Westphalia | 53840 | Germany |
| Novartis Investigative Site | Velbert | North Rhine-Westphalia | 42551 | Germany |
| Novartis Investigative Site | Altenkirchen | Rhineland-Palatinate | 57610 | Germany |
| Novartis Investigative Site | Chemnitz | Saxony | 09009 | Germany |
| Novartis Investigative Site | Dresden | Saxony | 01219 | Germany |
| Novartis Investigative Site | Kiel | Schleswig-Holstein | 24103 | Germany |
| Novartis Investigative Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| Novartis Investigative Site | Pinneberg | Schleswig-Holstein | 25421 | Germany |
| Novartis Investigative Site | Jena | Thuringia | 07743 | Germany |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Berlin | 10317 | Germany |
| Novartis Investigative Site | Berlin | 12200 | Germany |
| Novartis Investigative Site | Berlin | 14195 | Germany |
| Novartis Investigative Site | Hamburg | 20095 | Germany |
| Novartis Investigative Site | Hamburg | 20259 | Germany |
| Novartis Investigative Site | Hamburg | 22081 | Germany |
| Novartis Investigative Site | Hamburg | 22457 | Germany |
| Novartis Investigative Site | Hamburg | 22767 | Germany |
| Novartis Investigative Site | Budapest | 1032 | Hungary |
| Novartis Investigative Site | Budapest | 1088 | Hungary |
| Novartis Investigative Site | Budapest | 1096 | Hungary |
| Novartis Investigative Site | Kecskemét | 6000 | Hungary |
| Novartis Investigative Site | Kistarcsa | 2143 | Hungary |
| Novartis Investigative Site | Szeged | 6720 | Hungary |
| Novartis Investigative Site | Tatabánya | 2800 | Hungary |
| Novartis Investigative Site | Cork | Ireland |
| Novartis Investigative Site | Dooradoyle | Ireland |
| Novartis Investigative Site | Dublin | 4 | Ireland |
| Novartis Investigative Site | Dublin | 8 | Ireland |
| Novartis Investigative Site | Dublin | 9 | Ireland |
| Novartis Investigative Site | Galway | Ireland |
| Novartis Investigative Site | Tallaght, Dublin | 24 | Ireland |
| Novartis Investigative Site | Wilton, Cork | Ireland |
| Novartis Investigative Site | Bologna | Emilia-Romagna | 40138 | Italy |
| Novartis Investigative Site | Parma | Emilia-Romagna | 43100 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00133 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00152 | Italy |
| Novartis Investigative Site | Genoa | Liguria | 16128 | Italy |
| Novartis Investigative Site | Genoa | Liguria | 16132 | Italy |
| Novartis Investigative Site | Crema | Lombardy | 26013 | Italy |
| Novartis Investigative Site | Milan | Lombardy | 20162 | Italy |
| Novartis Investigative Site | Acapulco de Juárez | Guerrero | 39670 | Mexico |
| Novartis Investigative Site | Colima | 28010 | Mexico |
| Novartis Investigative Site | Durango | 34000 | Mexico |
| Novartis Investigative Site | Durango | 34079 | Mexico |
| Novartis Investigative Site | Mexico City | 14050 | Mexico |
| Novartis Investigative Site | Amersfoort | 3813 TZ | Netherlands |
| Novartis Investigative Site | Delft | 2625 AD | Netherlands |
| Novartis Investigative Site | Doetinchem | 7009 BL | Netherlands |
| Novartis Investigative Site | Eindhoven | 5623 EJ | Netherlands |
| Novartis Investigative Site | Heerlen | 6419 PC | Netherlands |
| Novartis Investigative Site | Leidschendam | 2262 BA | Netherlands |
| Novartis Investigative Site | Maastricht | 6229 HX | Netherlands |
| Novartis Investigative Site | Nieuwegein | 3435 CM | Netherlands |
| Novartis Investigative Site | Sittard-geleen | 6162 BG | Netherlands |
| Novartis Investigative Site | The Hague | 2512 VA | Netherlands |
| Novartis Investigative Site | The Hague | 2545 CH | Netherlands |
| Novartis Investigative Site | Utrecht | 3582 KE | Netherlands |
| Novartis Investigative Site | Utrecht | 3584 CX | Netherlands |
| Novartis Investigative Site | Christchurch | 8001 | New Zealand |
| Novartis Investigative Site | Lahore | 54000 | Pakistan |
| Novartis Investigative Site | Lahore | Pakistan |
| Novartis Investigative Site | Rawalpindi | 46000 | Pakistan |
| Novartis Investigative Site | Callao | Callao 2 | Peru |
| Novartis Investigative Site | Lima | Lima 34 | Peru |
| Novartis Investigative Site | Bydogoszcz | 85-796 | Poland |
| Novartis Investigative Site | Krakow | 31-115 | Poland |
| Novartis Investigative Site | Poznan | 61-866 | Poland |
| Novartis Investigative Site | Warsaw | 02-781 | Poland |
| Novartis Investigative Site | Wroclaw | 53-413 | Poland |
| Novartis Investigative Site | Moscow | 107005 | Russia |
| Novartis Investigative Site | Moscow | 115 478 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197758 | Russia |
| Novartis Investigative Site | Capital Park | 0002 | South Africa |
| Novartis Investigative Site | Panorama | 7500 | South Africa |
| Novartis Investigative Site | Parktown | 2193 | South Africa |
| Novartis Investigative Site | Port Elizabeth | 6001 | South Africa |
| Novartis Investigative Site | Gyeonggi-do | 411-769 | South Korea |
| Novartis Investigative Site | Seodaemun-gu, Seoul | 03722 | South Korea |
| Novartis Investigative Site | Seoul | 135-710 | South Korea |
| Novartis Investigative Site | Alcala de Henares (Madrid) | Spain |
| Novartis Investigative Site | Badalona | 08916 | Spain |
| Novartis Investigative Site | Barcelona | 08036 | Spain |
| Novartis Investigative Site | Donostia / San Sebastian | 20014 | Spain |
| Novartis Investigative Site | Elche | 03203 | Spain |
| Novartis Investigative Site | Girona | 17007 | Spain |
| Novartis Investigative Site | Leganes, Madrid | 28911 | Spain |
| Novartis Investigative Site | Madrid | 28007 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Madrid | 28035 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Málaga | 29010 | Spain |
| Novartis Investigative Site | Móstoles | 28935 | Spain |
| Novartis Investigative Site | Oviedo | 33006 | Spain |
| Novartis Investigative Site | Palma de Mallorca | 07010 | Spain |
| Novartis Investigative Site | Valencia | 46010 | Spain |
| Novartis Investigative Site | Vigo ( Pontevedra) | 36204 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Sfax | 3000 | Tunisia |
| Novartis Investigative Site | Sousse | 4000 | Tunisia |
| Novartis Investigative Site | Tunis | 1004 | Tunisia |
| Novartis Investigative Site | Tunis | 1007 | Tunisia |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34865 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | Turkey (Türkiye) |
| Novartis Investigative Site | Chelmsford | Essex | CM1 7ET | United Kingdom |
| Novartis Investigative Site | Manchester | Lancashire | M20 4BX | United Kingdom |
| Novartis Investigative Site | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Novartis Investigative Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| Novartis Investigative Site | Birmingham | West Midlands | B18 7QH | United Kingdom |
| Novartis Investigative Site | Huddersfield | HD3 3EA | United Kingdom |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Novartis Investigative Site | London | SW17 0QT | United Kingdom |
| Novartis Investigative Site | London | SW3 6JJ | United Kingdom |
| Novartis Investigative Site | Sheffield | S10 2SJ | United Kingdom |
| Background |
| Schwartzberg LS, Franco SX, Florance A, O'Rourke L, Maltzman J, Johnston S. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist. 2010;15(2):122-9. doi: 10.1634/theoncologist.2009-0240. Epub 2010 Feb 15. |
| 20798196 | Background | Sherrill B, Amonkar MM, Sherif B, Maltzman J, O'Rourke L, Johnston S. Quality of life in hormone receptor-positive HER-2+ metastatic breast cancer patients during treatment with letrozole alone or in combination with lapatinib. Oncologist. 2010;15(9):944-53. doi: 10.1634/theoncologist.2010-0012. Epub 2010 Aug 26. |
| 24198242 | Background | Finn RS, Press MF, Dering J, O'Rourke L, Florance A, Ellis C, Martin AM, Johnston S. Quantitative ER and PgR assessment as predictors of benefit from lapatinib in postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. Clin Cancer Res. 2014 Feb 1;20(3):736-43. doi: 10.1158/1078-0432.CCR-13-1260. Epub 2013 Nov 6. |
| 27281556 | Background | Prat A, Cheang MC, Galvan P, Nuciforo P, Pare L, Adamo B, Munoz M, Viladot M, Press MF, Gagnon R, Ellis C, Johnston S. Prognostic Value of Intrinsic Subtypes in Hormone Receptor-Positive Metastatic Breast Cancer Treated With Letrozole With or Without Lapatinib. JAMA Oncol. 2016 Oct 1;2(10):1287-1294. doi: 10.1001/jamaoncol.2016.0922. |
| 29522361 | Derived | Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9. |
| FG001 | Lapatinib 1500 mg + Letrozole 2.5 mg | Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Letrozole 2.5 mg | Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. |
| BG001 | Lapatinib 1500 mg + Letrozole 2.5 mg | Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator | PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. | HER2-Positive Population: all randomized participants who had documented amplification of baseline HER2 by fluorescence in situ hybridization (FISH) (=>2.0) or 3+ immunohistochemistry (IHC) (or 2+ IHC and FISH +) in archived tumor tissue regardless of whether or not study treatment had been received. | Posted | Count of Participants | Participants | From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator | PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. | HER2-Positive Population. Only those participants who experienced disease progression or died during their participation in the study were assessed. | Posted | Median | 95% Confidence Interval | Weeks | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator | PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. | ITT Population: all randomized participants, regardless of whether or not study treatment had been received. The ITT Population included the HER2-Positive Population, the HER2-Negative Population, and the HER2-Missing Population. | Posted | Count of Participants | Participants | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS in Participants in the ITT Population as Assessed by the Investigator | PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. | ITT Population. Only those participants who experienced disease progression or died during their participation in the study were assessed. | Posted | Median | 95% Confidence Interval | Weeks | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival in the HER2-Positive Population | Overall survival was defined as the time from randomization until death due to any cause. | HER2-Positive Population. Only those participants who died during the study due to any cause were assessed. | Posted | Median | 95% Confidence Interval | Weeks | From date of randomization until date of death due to any cause, assessed up to 46 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator | OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. | HER2-Positive Population | Posted | Number | 95% Confidence Interval | Percent response rate | Up to 46 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator | Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT to the randomization date. | HER2-Positive Population. Only those participants with measurable disease, including bone scans, were assessed. | Posted | Count of Participants | Participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator | CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement. | HER2-Positive Population | Posted | Number | 95% Confidence Interval | Months | Up to 46 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator. | CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions. | HER2-Positive Population | Posted | Count of Participants | Participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator. | CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions. | ITT Population | Posted | Count of Participants | Participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator | Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans. | HER2-Positive Population. Only those participants with CR or PR were assessed. | Posted | Count of Participants | Participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator | Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans. | HER2-Positive Population. Only those participants with CR or PR were assessed. | Posted | Median | Inter-Quartile Range | weeks | Up to 46 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population | The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another. | HER2-Positive Population | Posted | Number | participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator | TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator. | HER2-Positive Population. Only those participants who experienced disease progression or died due to breast cancer were assessed. | Posted | Median | 95% Confidence Interval | weeks | Up to 46 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival in the ITT Population | Overall survival was defined as the time from randomization until death due to any cause. | ITT Population. Only those participants who died during the study due to any cause were assessed. | Posted | Median | 95% Confidence Interval | weeks | From date of randomization until date of death due to any cause, assessed up to 46 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator | OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. | ITT Population. Only those participants who achieved either a confirmed CR or PR were assessed. | Posted | Number | percentage of participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator | Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT and the randomization date. | ITT Population. Only those participants with some measurable disease were assessed. Response with bone scan confirmation was required. Participants with bone-only disease were excluded from the analysis because bone-only disease is non-measurable only per RECIST 1.0. | Posted | Number | participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator | CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement. | ITT Population | Posted | Number | percentage of participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator | Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans. | ITT Population. Only those participants with CR or PR were assessed. | Posted | Number | participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator | Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans. | ITT Population. Only those participants with CR or PR response were assessed. | Posted | Median | Inter-Quartile Range | weeks | Up to 46 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Evidence of Brain Metastases From the ITT Population | The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another. | ITT Population | Posted | Number | participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTP for Participants From the ITT Population as Assessed by the Investigator | TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator. | ITT Population. Only those participants who experienced disease progression or died due to breast cancer were assessed. | Posted | Median | 95% Confidence Interval | weeks | Up to 46 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits | Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales (each ranging from 0 [not at all] to 4 [very much]) indicate a higher QOL. The score is transformed for FACT-B and results in a total score ranging from 0 to 144. Complete: completing at least 1 question from FACT-B. | ITT Population | Posted | Count of Participants | Participants | Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data | Quality of Life (QOL) was assessed using the FACT-B questionnaire, which is a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144. The FACT-B is designed to measure multidimensional QOL in participants with breast cancer. | HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed. | Posted | Number | Adjusted mean change | Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data | FACT-G is a subscale of the FACT-B QOL questionnaire and consists of 27 questions grouped into 4 domains that measure a participant's physical, functional, social and family, and emotional well-being. FACT-G is assessed on a five-point Likert-type scale, with scores ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total score is calculated as the sum of the item scores on the subscale; the total ranges from 0 to 108, with higher score indicating a better quality of life. | HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed. | Posted | Number | Adjusted mean change | Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data | The TOI score is the sum of the physical well-being, functional well-being, and breast cancer unweighted subscale scores. The total TOI score ranges from 0 to 92, with higher scores representing a better quality of life. | HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed. | Posted | Number | Adjusted mean change | Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores | A minimally important difference (MID) is the smallest difference in a score for a measure of QOL that corresponds to a difference in function or clinical course. Responders are defined as participants with an MID => 8 for the FACT-B score, and an MID =>6 for the FACT-G and TOI scores. | HER2-Positive Population. Only those participants with a baseline score and at least one post-baseline score were assessed. | Posted | Count of Participants | Participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status | Clinical benefit: participants with CR, PR, or SD for =>6-month period. FISH testing measures the amount of the HER2 gene in each cell. This gene is responsible for the overproduction of the HER2 protein. FISH-positive: excessive amounts of the gene are present; FISH-negative: normal levels of the gene are present. | ITT Population | Posted | Count of Participants | Participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity | IHC is a commonly used test to assess the amount of the HER2 receptor protein on the surface of the cancer cells. The IHC test results in a score of 0 to 3+, which indicates the amount of HER2 receptor protein on the cells in a sample of breast cancer tissue. Tissue scores of 0 to 1+ indicate HER2 negativity; scores of 2+ and 3+ indicate HER2 positivity. Clinical benefit is defined as participants with CR, PR, or SD for =>6-month period. | ITT Population | Posted | Count of Participants | Participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower | The HER2 ECD is a glycoprotein that can be shed from the cell surface into the blood of normal individuals and can be elevated in different pathologic conditions. The serum HER2 ECD level generally reflects the tissue HER2 status. The HER2 ECD is quantified in serum with an enzyme-linked immunosorbent assay (ELISA). Non-Evaluable (NE): any participant who could not be classified as CR, PR, SD, or PD. | HER2-Positive Population | Posted | Count of Participants | Participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive | Participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL experienced seroconversion. | HER2-Negative Population: all randomized participants regardless of whether or not study treatment had been received and who at baseline were evaluated by the central laboratory to have retrospectively documented non-amplification or missing amplification of HER2 by FISH (<2.0) and documented IHC scores of 0, 1+, 2+, or missing in tumor tissue. | Posted | Count of Participants | Participants | Up to 46 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive | Time to seroconversion was defined as the time from the date of randomization until the first instance of serum HER2 (>15 ng/mL) on two consecutive occasions. | HER2-Negative Population. Only those participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL were assessed. | Posted | Median | 95% Confidence Interval | Weeks | Up to 46 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline | EGFR is a cell surface receptor tyrosine kinase expressed in certain types of tumors. Depending upon the staining intensity, EGFR was graded as follows: 0=absence of membrane staining above background in all tumor cells; EGFR-positive=staining is defined as any IHC staining of tumor cell membranes above background level, whether it is complete or incomplete circumferential staining (1+, 2+, 3+). | ITT Population | Posted | Count of Participants | Participants | Baseline |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | All Collected Deaths | On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 663.9 weeks (treatment duration ranged from 0.1 to 659.9 weeks). Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 14 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored. | Clinical database population; all treated patients. | Posted | Count of Participants | Participants | up to 663 weeks (on-treatment), up to approximately 14 years (study duration) |
|
Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 663.9 weeks (treatment duration ranged from 0.1 to 659.9 weeks).
Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to Lapatinib = 612 weeks (Lapatinib + Letrozole treatment group). Maximum exposure to Letrozole = 659.7 weeks (Placebo + Letrozole treatment group) and 612 weeks (Lapatinib + Letrozole treatment group).
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 | Placebo + Letrozole 2.5 mg | Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. | 23 | 624 | 103 | 624 | 481 | 624 |
| EG001 | Lapatinib 1500 mg + Letrozole 2.5 mg | Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. | 18 | 654 | 150 | 654 | 589 | 654 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Jaundice | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral swelling | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Deafness bilateral | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Carcinoid tumour | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercalcaemia | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eye injury | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Colon cancer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oral infection | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pancreatitis haemorrhagic | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peritonitis bacterial | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gallbladder pain | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Crohn's disease | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dermatomyositis | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pyelonephritis | 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 |
| |
| Tooth abscess | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Accidental poisoning | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Catheter site infection | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatotoxicity | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Post procedural infection | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Toxic skin eruption | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Uterine perforation | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Wound infection | 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 alkaline phosphatase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood urea 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 |
| |
| Hepatic enzyme increased | Investigations | 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 |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoglycaemia | 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 |
| |
| Iron deficiency anaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ankle fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthritis | 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 |
| |
| Cervical vertebral fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Femoral neck fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Femur fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gait disturbance | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hip fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Humerus fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Spinal compression fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Spinal fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tibia fracture | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Ovarian cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Confusional state | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Meningioma | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA (20.1) | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (20.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatorenal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercreatininaemia | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pelvic pain | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Breast abscess | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Breast cellulitis | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ovarian enlargement | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleuritic pain | 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 |
| |
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Herpes zoster | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Incision site cellulitis | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Infected skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Malignant melanoma | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Paronychia | 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 |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Angina unstable | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematemesis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematochezia | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoptysis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemorrhoids thrombosed | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Melaena | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myocardial infarction | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Uterine haemorrhage | 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 |
| |
| Dyspnoea | Cardiac 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 |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | 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 alkaline phosphatase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | 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 |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal 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 |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Alopecia | 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 |
| |
| Paronychia | 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 |
|
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 |
| 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 |
|---|---|
| D000077341 | Lapatinib |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| American Hispanic |
|
| Other |
|
Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib.
|
|
|
Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
|
|
Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. |
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|