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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000564-81 | EudraCT Number | ||
| CLAP016B2302 | Other Identifier | Novartis |
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| Name | Class |
|---|---|
| Breast International Group | OTHER |
| SOLTI Breast Cancer Research Group | OTHER |
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This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer.
Patients will be randomised to receive either: lapatinib 1500 mg daily, trastuzumab 4 mg/kg intravenous (IV) load followed by 2 mg/kg IV weekly, or lapatinib 1000 mg daily with trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for a total of 6 weeks. After this biological window, patients on monotherapy arms will continue on the same targeted therapy plus weekly paclitaxel 80 mg/m^2 for a further 12 weeks, up to definitive surgery. In the combination arm, patients will receive lapatinib 750 mg daily in combination with trastuzumab 2 mg/kg IV plus weekly paclitaxel 80mg/m^2 IV for a further 12 weeks, up to definitive surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with 5-Fluorouracil Epirubicin Cyclophosphamide (FEC) followed by the same targeted therapy as in the biological window of the neoadjuvant setting for a further 34 weeks (in the combination arm, lapatinib dose will be 1000 mg daily in combination with trastuzumab). The planned total duration of the anti-HER2 therapy one year.
Primary objective is to evaluate and compare the rate of pathological complete response (pCR) at the time of surgery in patients with HER2/ErbB2 overexpressing or amplified operable breast cancer randomised to lapatinib followed by lapatinib plus paclitaxel versus trastuzumab followed by trastuzumab plus paclitaxel versus lapatinib in combination with trastuzumab followed by lapatinib, trastuzumab plus paclitaxel.
This was a parallel group, three-arm, randomized, multicenter, open-label phase III study. The study compared the efficacy and tolerability of neoadjuvant lapatinib and paclitaxel, versus trastuzumab and paclitaxel, versus the combination of lapatinib with trastuzumab and paclitaxel given as neoadjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer. Subjects were randomized to receive lapatinib, trastuzumab or lapatinib plus trastuzumab for a total of 6 weeks. After this biological window, subjects continued on the same targeted therapy plus weekly paclitaxel for a further 12 weeks, until definitive surgery (total neoadjuvant therapy duration of 18 weeks). Paclitaxel could be initiated at Week 4 if there is evidence of progressive disease (PD) at that time. Within 6 weeks after surgery, subjects received 3 cycles of adjuvant 5-flourouracil, epirubicin and cyclophosphamide (FEC) followed by the same targeted therapy as in the biological window of the neoadjuvant phase for a further 34 weeks (to complete 52 weeks of anti-HER2 therapy).
After completing 52 weeks of (neo-)/adjuvant anti-HER2 therapy, subjects were scheduled to attend post-treatment follow-up every 3 months during the first year (months 12, 15, 18, 21, and 24), every 6months in Years 3 to 5 inclusive, and annually thereafter up to Year 10. Each subject was to be followed for 10 Years. All subjects were to be followed for EFS and OS up to 10 years from last subject randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Lapatinib | Experimental | 1500 mg lapatinib for 6 weeks followed by lapatinib plus weekly paclitaxel for an additional 12 weeks. After definitive surgery, 3 cycles of adjuvant FEC followed by 34 weeks of adjuvant lapatinib. |
|
| Arm 2 Trastuzumab | Active Comparator | 4 mg/kg IV loading dose followed by 2 mg/kg IV weekly trastuzumab for 6 weeks followed by 2 mg/kg trastuzumab plus weekly paclitaxel for an additional 12 weeks. After definitive surgery, 3 cycles of adjuvant FEC followed by 34 weeks of adjuvant trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks). |
|
| Arm 3 Lapatinib plus Trastuzumab | Experimental | 1000 mg lapatinib plus 4 mg/kg IV loading dose followed by 2 mg/kg IV weekly trastuzumab for 6 weeks, followed by 750 mg lapatinib plus 2 mg/kg IV weekly trastuzumab plus weekly paclitaxel for an additional 12 weeks. After definitive surgery, 3 cycles of adjuvant FEC followed by 34 weeks of adjuvant lapatinib (1000 mg) in combination with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lapatinib | Drug | Small molecule receptor tyrosine kinase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery | Pathological complete response is defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to National Surgical Adjuvant Breast and Bowel Project (NSABP) guidelines, which do not take into account the histological nodal status. | Weeks 20 to 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Response at Week 6 | The number of participants with overall response (complete response and/or partial response) was evaluated using World Health Organization (WHO) criteria by clinical examination and by mammography and breast echography with bi-dimensional measurements at Week 6. As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berazategui | Buenos Aires | B1880BBF | Argentina | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Baselga J, Piccart M, Gelber R, di CosimoS, Viale G, Koehler M, Rojo F. Neo-ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study [BIG 1-06 /solti/EGF106903]: a phase III translational study for HER2-overexpressing early breast cancer. [Lancet]. 2012;S140-6736(11): | ||
| 39613746 | Derived | Rediti M, Venet D, Joaquin Garcia A, Maetens M, Vincent D, Majjaj S, El-Abed S, Di Cosimo S, Ueno T, Izquierdo M, Piccart M, Pusztai L, Loi S, Salgado R, Viale G, Rothe F, Sotiriou C. Identification of HER2-positive breast cancer molecular subtypes with potential clinical implications in the ALTTO clinical trial. Nat Commun. 2024 Nov 29;15(1):10402. doi: 10.1038/s41467-024-54621-3. | |
| 35610260 |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg | Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Trastuzumab | Biological | Therapeutic Monoclonal Antibody |
|
| Paclitaxel | Drug | antimicrotubule agent |
|
| Week 6 |
| Overall Response at the Time of Surgery | The number of participants with overall response (complete response and/or partial response) was evaluated using WHO criteria by clinical examination and mammography and breast echography with bi-dimensional measurements at the time of surgery (Weeks 20 to 22). As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions. | Time of surgery (Weeks 20 to 22) |
| Number of Participants With Negative Lymph Nodes at the Time of Surgery | Participants were assessed for node-negative lymph nodes at the time of surgery. As per the pathological TNM (Tumor, Node, Metastases) classification (pTNM) of malignant tumors: pN, absence or presence and extent of regional lymph node metastasis. Node-negative (pN0) participants had no regional lymph node metastasis. Although not assessed in this measure, pT is the extent of primary tumor, and pM is the absence or presence of distant metastasis. | Time of surgery (Weeks 20 to 22) |
| Number of Participants With Actual Indicated Surgery | Participants were assessed for the type of surgery they underwent for breast cancer. Non-conservative surgery is defined as a radical or modified radical mastectomy. Conservative surgery is comprised of a lumpectomy, a quadrantectomy/segmentectomy, or a partial mastectomy. Participants who were not assessed as being candidates for non-conservative or conservative surgery were classified as non-operable. | At surgery (Weeks 20 to 22) |
| Mean Change From Baseline in Tumor Size at Week 6 and at Surgery | Mean change from baseline in tumor in tumor size. Change from baseline in tumor size was defined as tumor size at Week 6/ surgery (Weeks 20 to 22) minus tumor size at baseline. The difference in treatment arms was estimated for Lapatinib 1500 mg versus Trastuzumab 2 mg/kg and for Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg versus Trastuzumab 2 mg/kg. | Week 6 and surgery (Weeks 20 to 22) |
| Number of Participants Starting Paclitaxel Before Completing 6 Weeks of Treatment With Either Lapatinib or Trastuzumab | Participants with progressive disease at 4 week assessment that were permitted to commence treatment with paclitaxel. | Week 6 |
| Event-free Survival (EFS) - Median Clinical Follow-up | Event free survival (EFS) is defined as the time from randomization to first EFS event. For subjects who had breast cancer surgery, EFS events were post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For subjects who did not have breast cancer surgery, EFS events were death during clinical follow-up or non-completion of any neoadjuvant investigational product due to disease progression. | From randomization up to approximately year 10 |
| Event-free Survival (EFS) - Events and Censoring | Event free survival (EFS) is defined as the time from randomization to first EFS event. For subjects who had breast cancer surgery, EFS events were post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For subjects who did not have breast cancer surgery, EFS events were death during clinical follow-up or non-completion of any neoadjuvant investigational product due to disease progression. | From randomization up to approximately year 10 |
| Overall Survival (OS) - Median Survival Follow-up | Overall survival is defined as the period from randomization until death (from any cause). OS was assessed annually for up to 10 years after the randomization of the last participant into the study. | From randomization up to approximately year 10 |
| Overall Survival (OS) - Deaths and Censoring | Overall survival is defined as the period from randomization until death (from any cause). OS was assessed annually for up to 10 years after the randomization of the last participant into the study. | From randomization up to approximately year 10 |
| Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Median Clinical Follow-up (EFS Landmark Population) | The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. Clinical follow-up is the period during which the patient is monitored such that all recurrence or second primary malignancy (SPM) or contralateral breast cancer (CBC) events would be reported. Patients are considered in clinical follow-up from randomisation until one of the following occurs: lost to follow-up, withdrawal of consent, end of follow-up due to completion of year 10 visit, termination of study follow-up, or death. | up to year 10 |
| Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Number of Participants With EFS Events (EFS Landmark Population) | The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. For patients who had breast cancer surgery, EFS events are post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For patients who do not undergo breast cancer surgery, EFS events are death during clinical follow-up or non-completion of any neo-adjuvant investigational product due to disease progression or second primary malignancy or contralateral breast cancer. | up to year 10 |
| Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Median Clinical Follow-up (OS Landmark Population) | The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. Patients are considered in survival follow-up from randomisation until one of the following occurs: lost to follow-up, withdrawal of consent, end of follow-up due to completion of year 10 visit, termination of study follow-up, or death. For subjects with no death recorded in the database, time to death is censored. | up to year 10 |
| Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Number of Participants Who Died (OS Landmark Population) | The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. Includes deaths due to any cause. | up to year 10 |
| To Assess Safety Via a Comparison of the Three Treatment Arms - to Measure On-treatment Primary Cardiac Endpoints | Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks. |
| Metabolic Response Rate Determined by Positron Emission Tomography/Computed Tomography (PET/CT) | Metabolic Response Rate determined by Positron Emission Tomography/Computed Tomography (PET/CT) | Week 2 and Week 6 |
| Percentage of Participants With the Indicated Biomarker Expression - PIK3CA. | Biomarker levels of phosphatidylinositol 3-kinase (PI3K) catalytic subunit (PIK3CA) were assessed in participants at baseline. | Baseline |
| Percentage of Participants With the Indicated Biomarker Expression - PTEN. | Biomarker levels of phosphate and tensin homolog deleted from chromosome 10 (PTEN) were assessed in participants at baseline. | Baseline |
| Ratio (95% CI) of Geometric Means in p95HER2 Expression in HR Positive Patients With pCR vs no pCR | Ratio (95% CI) of geometric means in p95 human epidermal growth factor receptor (p95HER2) expression in hormone-receptor (HR) positive patients with pathological complete response (pCR) vs no pCR | Baseline |
| Percentage of Participants With Circulating Tumor Cells (CTC) in the Bloodstream | Circulating tumor cells (CTCs) are cells that have detached from a primary tumor and circulate in the bloodstream. In the adjuvant phase, after surgery all participants received 3 courses of adjuvant 5-fluorouracil, epirubicin and cyclophosphamide, followed by lapatinib 1500 mg or trastuzumab 2 mg/kg or lapatinib 1000/750 mg plus trastuzumab 2 mg/kg given prior to surgery in the neoadjuvant setting for an additional 34 weeks. | Measurement performed at one or more of the time points: baseline, week 2 or week 18 |
| Ciudad Autonoma de Buenos Aires |
| Buenos Aires |
| C1125ABD |
| Argentina |
| Novartis Investigative Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1185AAT | Argentina |
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| Derived |
| Chumsri S, Li Z, Serie DJ, Norton N, Mashadi-Hossein A, Tenner K, Brauer HA, Warren S, Danaher P, Colon-Otero G, Partridge AH, Carey LA, Hilbers F, Van Dooren V, Holmes E, Di Cosimo S, Werner O, Huober JB, Dueck AC, Sotiriou C, Saura C, Moreno-Aspitia A, Knutson KL, Perez EA, Thompson EA. Adaptive immune signature in HER2-positive breast cancer in NCCTG (Alliance) N9831 and NeoALTTO trials. NPJ Breast Cancer. 2022 May 24;8(1):68. doi: 10.1038/s41523-022-00430-0. |
| 34921525 | Derived | Pizzamiglio S, Cosentino G, Ciniselli CM, De Cecco L, Cataldo A, Plantamura I, Triulzi T, El-Abed S, Wang Y, Bajji M, Nuciforo P, Huober J, Ellard SL, Rimm DL, Gombos A, Daidone MG, Verderio P, Tagliabue E, Di Cosimo S, Iorio MV. What if the future of HER2-positive breast cancer patients was written in miRNAs? An exploratory analysis from NeoALTTO study. Cancer Med. 2022 Jan;11(2):332-339. doi: 10.1002/cam4.4449. Epub 2021 Dec 17. |
| 29902299 | Derived | Powles RL, Redmond D, Sotiriou C, Loi S, Fumagalli D, Nuciforo P, Harbeck N, de Azambuja E, Sarp S, Di Cosimo S, Huober J, Baselga J, Piccart-Gebhart M, Elemento O, Pusztai L, Hatzis C. Association of T-Cell Receptor Repertoire Use With Response to Combined Trastuzumab-Lapatinib Treatment of HER2-Positive Breast Cancer: Secondary Analysis of the NeoALTTO Randomized Clinical Trial. JAMA Oncol. 2018 Nov 1;4(11):e181564. doi: 10.1001/jamaoncol.2018.1564. Epub 2018 Nov 8. |
| 27684533 | Derived | Fumagalli D, Venet D, Ignatiadis M, Azim HA Jr, Maetens M, Rothe F, Salgado R, Bradbury I, Pusztai L, Harbeck N, Gomez H, Chang TW, Coccia-Portugal MA, Di Cosimo S, de Azambuja E, de la Pena L, Nuciforo P, Brase JC, Huober J, Baselga J, Piccart M, Loi S, Sotiriou C. RNA Sequencing to Predict Response to Neoadjuvant Anti-HER2 Therapy: A Secondary Analysis of the NeoALTTO Randomized Clinical Trial. JAMA Oncol. 2017 Feb 1;3(2):227-234. doi: 10.1001/jamaoncol.2016.3824. |
| 26181252 | Derived | Salgado R, Denkert C, Campbell C, Savas P, Nuciforo P, Aura C, de Azambuja E, Eidtmann H, Ellis CE, Baselga J, Piccart-Gebhart MJ, Michiels S, Bradbury I, Sotiriou C, Loi S. Tumor-Infiltrating Lymphocytes and Associations With Pathological Complete Response and Event-Free Survival in HER2-Positive Early-Stage Breast Cancer Treated With Lapatinib and Trastuzumab: A Secondary Analysis of the NeoALTTO Trial. JAMA Oncol. 2015 Jul;1(4):448-54. doi: 10.1001/jamaoncol.2015.0830. |
| 25851628 | Derived | Nuciforo PG, Aura C, Holmes E, Prudkin L, Jimenez J, Martinez P, Ameels H, de la Pena L, Ellis C, Eidtmann H, Piccart-Gebhart MJ, Scaltriti M, Baselga J. Benefit to neoadjuvant anti-human epidermal growth factor receptor 2 (HER2)-targeted therapies in HER2-positive primary breast cancer is independent of phosphatase and tensin homolog deleted from chromosome 10 (PTEN) status. Ann Oncol. 2015 Jul;26(7):1494-500. doi: 10.1093/annonc/mdv175. Epub 2015 Apr 7. |
| 25130998 | Derived | de Azambuja E, Holmes AP, Piccart-Gebhart M, Holmes E, Di Cosimo S, Swaby RF, Untch M, Jackisch C, Lang I, Smith I, Boyle F, Xu B, Barrios CH, Perez EA, Azim HA Jr, Kim SB, Kuemmel S, Huang CS, Vuylsteke P, Hsieh RK, Gorbunova V, Eniu A, Dreosti L, Tavartkiladze N, Gelber RD, Eidtmann H, Baselga J. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response. Lancet Oncol. 2014 Sep;15(10):1137-46. doi: 10.1016/S1470-2045(14)70320-1. Epub 2014 Aug 14. |
| 22785351 | Derived | Yarden Y, Pines G. The ERBB network: at last, cancer therapy meets systems biology. Nat Rev Cancer. 2012 Jul 12;12(8):553-63. doi: 10.1038/nrc3309. |
| 22257673 | Derived | Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gomez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horvath Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012 Feb 18;379(9816):633-40. doi: 10.1016/S0140-6736(11)61847-3. Epub 2012 Jan 17. |
| Lapatinib 1500 mg |
Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks |
| FG002 | Trastuzumab 2 mg/kg | Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks |
| COMPLETED | Completed follow-up per protocol event free. Includes subjects who had a follow-up visit or phone call ≥ 9 years + 6 months after randomization and had no EFS events |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lapatinib 1500 mg | Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks |
| BG001 | Trastuzumab 2 mg/kg | Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks |
| BG002 | Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg | Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Number of participants with tumor cells of the indicated histologic grade | Histologic grade, also called differentiation, refers to how much the tumor cells resemble normal cells of the same tissue type. | Count of Participants | Participants |
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| Number of participants with lymph nodes (LNs) of the indicated clinical N stage | Clinical N stage is an evaluation/staging of LN status through physical examination. N0, no regional LN metastasis; N1, metastasis to movable ipsilateral axillary LNs (IALNs); N2a, metastasis in IALNs fixed to one another (matted) or the other structures; N2b, metastasis only in clinically apparent ipsilateral internal mammary nodes and in the absence of clinically evident axillary LN metastasis; N3a, metastasis in ipsilateral infraclavicular LNs; N3b, metastasis in ipsilateral internal mammary LNs fixed and axillary LN; N3c, metastasis in ipsilateral subclavicar LNs; Nx, not assessed. | Count of Participants | Participants |
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| Number of participants with the indicated IHC results | An Immunohistochemistry (IHC) test gives a score of 0 to 3+, which indicates the amount of Human Epidermal Growth Factor (HER2) receptor proteins on the cancer cells in the sample tissue. A positive score (3+) indicates that HER2 receptor protein is present, a negative score (0-1+) indicates that no HER2 receptor protein is present, and an equivocal score (2+) indicates uncertainty and a result that is open for interpretation. Equivocal results require additional testing. "Not applicable" refers to the number of participants who did not have IHC testing done. | Count of Participants | Participants |
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| Number of participants with the indicated FISH results | The Fluorescent In Situ Hybridization (FISH) assay was used to determine the overexpression and/or amplification of HER2 in the invasive component of the primary tumor. Amplified indicates that the cell is overexpressing copies of the HER2 gene. Not amplified indicates that there is no overexpression of copies of the HER2 gene. "Not applicable" refers to the number of participants who did not have the FISH assay performed. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery | Pathological complete response is defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to National Surgical Adjuvant Breast and Bowel Project (NSABP) guidelines, which do not take into account the histological nodal status. | Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication | Posted | Number | participants | Weeks 20 to 22 |
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| Secondary | Number of Participants With Overall Response at Week 6 | The number of participants with overall response (complete response and/or partial response) was evaluated using World Health Organization (WHO) criteria by clinical examination and by mammography and breast echography with bi-dimensional measurements at Week 6. As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions. | ITT Population | Posted | Number | participants | Week 6 |
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| Secondary | Overall Response at the Time of Surgery | The number of participants with overall response (complete response and/or partial response) was evaluated using WHO criteria by clinical examination and mammography and breast echography with bi-dimensional measurements at the time of surgery (Weeks 20 to 22). As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions. | ITT Population | Posted | Number | participants | Time of surgery (Weeks 20 to 22) |
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| Secondary | Number of Participants With Negative Lymph Nodes at the Time of Surgery | Participants were assessed for node-negative lymph nodes at the time of surgery. As per the pathological TNM (Tumor, Node, Metastases) classification (pTNM) of malignant tumors: pN, absence or presence and extent of regional lymph node metastasis. Node-negative (pN0) participants had no regional lymph node metastasis. Although not assessed in this measure, pT is the extent of primary tumor, and pM is the absence or presence of distant metastasis. | ITT Population. Participants with a lymph node status of pNX (i.e., regional lymph nodes cannot be assessed) were omitted from the analysis of node-negative participants. | Posted | Number | participants | Time of surgery (Weeks 20 to 22) |
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| Secondary | Number of Participants With Actual Indicated Surgery | Participants were assessed for the type of surgery they underwent for breast cancer. Non-conservative surgery is defined as a radical or modified radical mastectomy. Conservative surgery is comprised of a lumpectomy, a quadrantectomy/segmentectomy, or a partial mastectomy. Participants who were not assessed as being candidates for non-conservative or conservative surgery were classified as non-operable. | ITT Population | Posted | Number | participants | At surgery (Weeks 20 to 22) |
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| Secondary | Mean Change From Baseline in Tumor Size at Week 6 and at Surgery | Mean change from baseline in tumor in tumor size. Change from baseline in tumor size was defined as tumor size at Week 6/ surgery (Weeks 20 to 22) minus tumor size at baseline. The difference in treatment arms was estimated for Lapatinib 1500 mg versus Trastuzumab 2 mg/kg and for Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg versus Trastuzumab 2 mg/kg. | ITT Population | Posted | Mean | Standard Deviation | millimeters | Week 6 and surgery (Weeks 20 to 22) |
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| Secondary | Number of Participants Starting Paclitaxel Before Completing 6 Weeks of Treatment With Either Lapatinib or Trastuzumab | Participants with progressive disease at 4 week assessment that were permitted to commence treatment with paclitaxel. | ITT Population. Participants who did not start any treatment were excluded from analysis. | Posted | Number | participants | Week 6 |
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| Secondary | Event-free Survival (EFS) - Median Clinical Follow-up | Event free survival (EFS) is defined as the time from randomization to first EFS event. For subjects who had breast cancer surgery, EFS events were post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For subjects who did not have breast cancer surgery, EFS events were death during clinical follow-up or non-completion of any neoadjuvant investigational product due to disease progression. | Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication | Posted | Median | 95% Confidence Interval | years | From randomization up to approximately year 10 |
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| Secondary | Event-free Survival (EFS) - Events and Censoring | Event free survival (EFS) is defined as the time from randomization to first EFS event. For subjects who had breast cancer surgery, EFS events were post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For subjects who did not have breast cancer surgery, EFS events were death during clinical follow-up or non-completion of any neoadjuvant investigational product due to disease progression. | Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication | Posted | Number | Number of Participants | From randomization up to approximately year 10 |
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| Secondary | Overall Survival (OS) - Median Survival Follow-up | Overall survival is defined as the period from randomization until death (from any cause). OS was assessed annually for up to 10 years after the randomization of the last participant into the study. | Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication | Posted | Median | 95% Confidence Interval | years | From randomization up to approximately year 10 |
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| Secondary | Overall Survival (OS) - Deaths and Censoring | Overall survival is defined as the period from randomization until death (from any cause). OS was assessed annually for up to 10 years after the randomization of the last participant into the study. | Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication | Posted | Number | Number of Participants | From randomization up to approximately year 10 |
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| Secondary | Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Median Clinical Follow-up (EFS Landmark Population) | The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. Clinical follow-up is the period during which the patient is monitored such that all recurrence or second primary malignancy (SPM) or contralateral breast cancer (CBC) events would be reported. Patients are considered in clinical follow-up from randomisation until one of the following occurs: lost to follow-up, withdrawal of consent, end of follow-up due to completion of year 10 visit, termination of study follow-up, or death. | For EFS, the landmark population was the subset of the ITT population who have not had an EFS event within 30 weeks after randomization and were still in clinical follow-up. | Posted | Median | 95% Confidence Interval | years | up to year 10 |
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| Secondary | Assess Associations Between Locoregional Pathological Complete Response (pCR) and Event-free Survival (EFS) - Number of Participants With EFS Events (EFS Landmark Population) | The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. For patients who had breast cancer surgery, EFS events are post-surgery breast cancer relapse, second primary malignancy or death without recurrence. For patients who do not undergo breast cancer surgery, EFS events are death during clinical follow-up or non-completion of any neo-adjuvant investigational product due to disease progression or second primary malignancy or contralateral breast cancer. | For EFS, the landmark population was the subset of the ITT population who have not had an EFS event within 30 weeks after randomization and were still in clinical follow-up. | Posted | Number | Number of participants | up to year 10 |
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| Secondary | Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Median Clinical Follow-up (OS Landmark Population) | The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. Patients are considered in survival follow-up from randomisation until one of the following occurs: lost to follow-up, withdrawal of consent, end of follow-up due to completion of year 10 visit, termination of study follow-up, or death. For subjects with no death recorded in the database, time to death is censored. | For OS, the landmark population was the subset of the ITT population who were alive and were followed up for overall survival 30 weeks after randomization. | Posted | Median | 95% Confidence Interval | years | up to year 10 |
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| Secondary | Assess Associations Between Locoregional Pathological Complete Response (pCR) and and Overall Survival (OS) - Number of Participants Who Died (OS Landmark Population) | The landmark date is 30 weeks after a subject's randomization. Subjects with missing pCR status were not included in the landmark analysis. Includes deaths due to any cause. | For OS, the landmark population was the subset of the ITT population who were alive and were followed up for overall survival 30 weeks after randomization. | Posted | Number | Number of Participants | up to year 10 |
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| Secondary | To Assess Safety Via a Comparison of the Three Treatment Arms - to Measure On-treatment Primary Cardiac Endpoints | Safety population | Posted | Count of Participants | Participants | Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks. |
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| Secondary | Metabolic Response Rate Determined by Positron Emission Tomography/Computed Tomography (PET/CT) | Metabolic Response Rate determined by Positron Emission Tomography/Computed Tomography (PET/CT) | Translational Data Set. Note that evaluable samples were not available for all participants. | Posted | Number | Percentage of participants | Week 2 and Week 6 |
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| Secondary | Percentage of Participants With the Indicated Biomarker Expression - PIK3CA. | Biomarker levels of phosphatidylinositol 3-kinase (PI3K) catalytic subunit (PIK3CA) were assessed in participants at baseline. | Translational Data Set. Note that evaluable samples were not available for all participants. | Posted | Number | Percentage of participants | Baseline |
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| Secondary | Percentage of Participants With the Indicated Biomarker Expression - PTEN. | Biomarker levels of phosphate and tensin homolog deleted from chromosome 10 (PTEN) were assessed in participants at baseline. | Translational Data Set. Note that evaluable samples were not available for all participants. | Posted | Number | Percentage of participants | Baseline |
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| Secondary | Ratio (95% CI) of Geometric Means in p95HER2 Expression in HR Positive Patients With pCR vs no pCR | Ratio (95% CI) of geometric means in p95 human epidermal growth factor receptor (p95HER2) expression in hormone-receptor (HR) positive patients with pathological complete response (pCR) vs no pCR | Translational Data Set. Note that evaluable samples were not available for all participants. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline |
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| Secondary | Percentage of Participants With Circulating Tumor Cells (CTC) in the Bloodstream | Circulating tumor cells (CTCs) are cells that have detached from a primary tumor and circulate in the bloodstream. In the adjuvant phase, after surgery all participants received 3 courses of adjuvant 5-fluorouracil, epirubicin and cyclophosphamide, followed by lapatinib 1500 mg or trastuzumab 2 mg/kg or lapatinib 1000/750 mg plus trastuzumab 2 mg/kg given prior to surgery in the neoadjuvant setting for an additional 34 weeks. | Translational Data Set. Note that evaluable samples were not available for all participants. | Posted | Number | Percentage of Participants | Measurement performed at one or more of the time points: baseline, week 2 or week 18 |
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| Post-Hoc | All Collected Deaths | On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, which was approximately 31 weeks. Deaths post treatment survival follow up were collected after the on treatment period, up to 10 years. | Safety population (for on-treatment deaths) and ITT (for total deaths) | Posted | Number | Participants | on-treatment: up to week 31; post-treatment: up to year 10 |
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Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 31 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg | Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks | 1 | 149 | 61 | 149 | 147 | 149 |
| EG001 | Lapatinib 1500 mg | Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks | 2 | 151 | 58 | 151 | 148 | 151 |
| EG002 | Trastuzumab 2 mg/kg | Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks | 0 | 148 | 36 | 148 | 141 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGRANULOCYTOSIS | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| ANAEMIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| DUODENITIS | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| ENTERITIS | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| PANCREATITIS | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA (23.0) | Systematic Assessment |
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| CHEST DISCOMFORT | General disorders | MedDRA (23.0) | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA (23.0) | Systematic Assessment |
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| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (23.0) | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA (23.0) | Systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
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| HEPATITIS ACUTE | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
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| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
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| HYPERTRANSAMINASAEMIA | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
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| APPENDICITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| BACTERIAL SEPSIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| BREAST CELLULITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| CELLULITIS STAPHYLOCOCCAL | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| DEVICE RELATED INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| DEVICE RELATED SEPSIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| ERYSIPELAS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| HEPATITIS B | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| HERPES SIMPLEX | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| HERPES ZOSTER | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| MASTITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| WOUND INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| POISONING | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| SEROMA | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| TRANSFUSION REACTION | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (23.0) | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
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| HYPERPHOSPHATASAEMIA | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
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| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
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| OSTEOPOROTIC FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| LOBULAR BREAST CARCINOMA IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
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| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| SCIATICA | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
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| NEPHRECTASIA | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
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| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
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| METRORRHAGIA | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
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| VULVOVAGINAL PRURITUS | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ORGANISING PNEUMONIA | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| JUGULAR VEIN THROMBOSIS | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA (23.0) | Systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | MedDRA (23.0) | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| VISUAL IMPAIRMENT | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ANAL INFLAMMATION | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| EPIGASTRIC DISCOMFORT | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| AXILLARY PAIN | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| FACE OEDEMA | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| FEELING COLD | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| GENERALISED OEDEMA | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MUCOSAL DRYNESS | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MUCOSAL EROSION | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPERTRANSAMINASAEMIA | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| HERPES SIMPLEX | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| MASTITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| NAIL INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| PARONYCHIA | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| PUSTULE | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| VAGINAL INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| SEROMA | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| NEUTROPHIL COUNT INCREASED | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPERPHOSPHATASAEMIA | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| JOINT STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| AGEUSIA | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| NEUROTOXICITY | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| POLYNEUROPATHY | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| TASTE DISORDER | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| SLEEP DISORDER | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| AMENORRHOEA | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| BREAST DISCHARGE | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| BREAST PAIN | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| MENSTRUATION IRREGULAR | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| VULVOVAGINAL DRYNESS | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| VULVOVAGINAL INFLAMMATION | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| VULVOVAGINAL PRURITUS | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| NASAL DRYNESS | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| NASAL INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| NAIL DYSTROPHY | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ONYCHALGIA | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| ONYCHOLYSIS | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PAIN OF SKIN | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| SCAR PAIN | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| SKIN FISSURES | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| SKIN IRRITATION | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| SKIN REACTION | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| LYMPHOEDEMA | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA (23.0) | 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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@Novartis.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010001 | Osteitis Deformans |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077341 | Lapatinib |
| D000068878 | Trastuzumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Asian - Central/South |
|
| Asian - East |
|
| Asian - South East |
|
| Black or African American/African Heritage |
|
| White - Arabic/North African Heritage |
|
| White - Caucasian European Heritage |
|
| Missing |
|
| Moderately differentiated |
|
| Poorly differentiated |
|
| Differentiation cannot be assessed |
|
| Missing |
|
| N1 |
|
| N2 (including N2a and N2b) |
|
| N3 (including N3a, N3b, and N3c) |
|
| Nx |
|
| Equivocal: Score of 2+ |
|
| Positive: Score of 3+ |
|
| Negative: Score of 0-1+ |
|
| Non interpretable |
|
| Amplified |
|
| Not amplified |
|
| Not interpretable |
|
| Binomial |
Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg |
| 0.0001 |
| Percentage of participants with pCR |
| 21.79 |
| 2-Sided |
| 97.5 |
| 9.08 |
| 34.23 |
Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm3 (Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg) minus Arm2 (Trastuzumab 2 mg/kg) |
| Superiority or Other (legacy) |
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
|
|
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
|
|
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Trastuzumab 2 mg/kg |
Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks |
|
|
| Trastuzumab 2 mg/kg |
Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks |
|
|
|
|
|
|
|
|
Overall - of the 3 arms
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
|
|
|
|