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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017905-13 | EudraCT Number |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab + Taxane (docetaxel or paclitaxel) | Experimental |
| |
| Trastuzumab emtansine + pertuzumab | Experimental |
| |
| Trastuzumab emtansine + pertuzumab placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | 75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment | Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Progression-Free Survival (PFS) According to IRF Assessment | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died Prior to Clinical Cutoff | The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center | Little Rock | Arkansas | 72204 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31146717 | Derived | Perez EA, de Haas SL, Eiermann W, Barrios CH, Toi M, Im YH, Conte PF, Martin M, Pienkowski T, Pivot XB, Burris HA 3rd, Stanzel S, Patre M, Ellis PA. Relationship between tumor biomarkers and efficacy in MARIANNE, a phase III study of trastuzumab emtansine +/- pertuzumab versus trastuzumab plus taxane in HER2-positive advanced breast cancer. BMC Cancer. 2019 May 30;19(1):517. doi: 10.1186/s12885-019-5687-0. | |
| 23837759 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab + Taxane | Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| paclitaxel | Drug | 80 mg/m2 intravenously weekly for a minimum of 18 weeks |
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| pertuzumab | Drug | 840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles |
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| pertuzumab-placebo | Drug | 840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles |
|
| trastuzumab [Herceptin] | Drug | trastuzumab [Herceptin] doses when administered with docetaxel: 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles or trastuzumab (Herceptin) doses when administered with paclitaxel: 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1. |
|
| trastuzumab emtansine | Drug | 3.6 mg/kg intravenously every 3 weeks |
|
| Overall Survival (OS) at Clinical Cutoff | OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method. | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
| Percentage of Participants With Death or Disease Progression According to Investigator Assessment | Tumor assessments were performed by the investigator according to RECIST version 1.1. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| PFS According to Investigator Assessment | Tumor assessments were performed by the investigator according to RECIST version 1.1. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Percentage of Participants Experiencing Treatment Failure | Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. The percentage of participants with treatment failure was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 |
| Time to Treatment Failure (TTF) | Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. TTF was defined as the time from randomization to treatment failure. Median TTF was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 |
| One-Year Survival Rate | The percentage of participants alive at 1 year after randomization was estimated as the one-year survival rate using Kaplan-Meier analysis, and corresponding CIs were computed using Greenwood's estimate of the standard error. | From randomization until 1 year |
| Percentage of Participants With Grade ≥3 Adverse Events | Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival. Grade 5: Death. | Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose |
| Percentage of Participants Who Died at 2 Years | From randomization until 2 years |
| Overall Survival Truncated at 2 Years | Overall Survival truncated at 2 years was defined as the percentage of participants alive at 2 years. | From randomization until 2 years |
| Percentage of Participants With Grade 5 Adverse Events | Adverse events were graded according to NCI CTCAE version 4.0. Grade 5 adverse events are those events which led to death. | Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose) |
| Percentage of Participants With Grade 3-4 Laboratory Parameters | Laboratory results were graded according to NCI CTCAE version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival. | Day 1, 8, and 15 of Cycle 1-3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014 |
| Percentage of Participants With Decline of ≥2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG performance status is a scale used to quantify cancer participants' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. | Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months) |
| Hospitalization Days | Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. Reported values represent number of days admitted per participants. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 |
| Percentage of Participants With Hospitalization | Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 |
| Percentage of Participants With Objective Response According to IRF Assessment | Objective response was defined as having complete response (CR) or partial response (PR), assessed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the objective response rate [ORR]) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method. | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Percentage of Participants With Objective Response According to Investigator Assessment | Objective response was defined as having CR or PR, assessed according to RECIST version 1.1, by investigator. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method. | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Duration of Response According to IRF Assessment | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Duration of response was defined as the time from confirmed PR or CR to first documented disease progression or death from any cause. CR was defined as the disappearance of all target lesions and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. Median duration of response was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method. | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient (20%) increase to qualify for disease progression. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR, PR, or SD was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score | The FACT-Taxane is a self-reported instrument which measures the health-related quality of life (HRQOL) of participants receiving taxane-containing chemotherapy. The FACT-TaxS consists of 16 items including 11 neurotoxicity-related questions and 5 additional questions assessing arthralgia, myalgia, and skin discoloration. Items are rated from 0 (not at all) to 4 (very much) and a total score is inversely derived. Scores may range from 0 to 64, with higher scores indicating fewer/no symptoms. A minimally clinically important difference in treatment-related symptoms was defined as a ≥5% decrease (ie, 3.2 points) in FACT-TaxS score from Baseline. The percentage of participants with treatment-related symptoms was calculated using following formula: [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method. | Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose) |
| Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module | The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with nausea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100. | At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2 |
| Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module | The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100. | At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2 |
| Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score | The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. The percentage of participants with deterioration was calculated as [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100. | Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose) |
| Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score | The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including PWB, SWB, EWB, FWB, and BCS. The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. Time to deterioration was defined as the time from Baseline until the first decrease in FACT-B TOI-PFB score. Median time to deterioration was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method. | Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014 |
| Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score | The RSCL is a self-reported instrument which consists of 4 domains including physical symptom distress, psychological distress, activity level, and overall global life quality. Only the activity level scale was collected and assessed. Scores may range from 0 to 100, with higher scores indicating increased burden of disease. Mean RSCL activity scale score changes were calculated as [mean score at the assessment visit minus mean score at Baseline]. The higher the score, the higher the level of impairment or burden. | Baseline, Cycle 7 (Week 18) |
| Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score | The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect) | Baseline, Cycle 7 (Week 18) |
| Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score | The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect). | Baseline, Cycle 7 (Week 18) |
| Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| PFS According to IRF Assessment Among Those With High HER2 mRNA Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis. | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels | The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
| OS at Clinical Cutoff Among Those With High HER2 mRNA Levels | OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis. | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
| Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels | The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
| OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels | OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis. Reported upper bound of confidence interval for "Trastuzumab Emtansine + Placebo" and confidence interval values for "Trastuzumab + Taxane" and "Trastuzumab Emtansine + Pertuzumab" are censored values. | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
| Scripps Cancer Center |
| La Jolla |
| California |
| 92037 |
| United States |
| University of California; Moores Cancer Center | La Jolla | California | 92093 | United States |
| Clnc L Trials & Rsch Assoc-Inc | Montebello | California | 90640 | United States |
| Southern California Kaiser Permanente | San Diego | California | 92108 | United States |
| Breastlink Medical Group Inc | Santa Ana | California | 92705 | United States |
| Kaiser Permanente; Oncology Clinical Trials | Vallejo | California | 94589 | United States |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06510 | United States |
| Innovative Medical Research of South Florida | Aventura | Florida | 33180 | United States |
| Northwest Oncology/ Hematology Assoc. | Coral Springs | Florida | 33065-5701 | United States |
| Florida Cancer Specialists; SCRI | Fort Myers | Florida | 33901 | United States |
| Mayo Clinic-Jacksonville | Jacksonville | Florida | 32224 | United States |
| Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| University Cancer & Blood Center, LLC; Research | Athens | Georgia | 30607 | United States |
| Cancer Research Center of Hawaii; Clinical Sciences | Honolulu | Hawaii | 96813 | United States |
| Mountain States Tumor Inst. | Boise | Idaho | 83712 | United States |
| Uni of Chicago | Chicago | Illinois | 60637 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Loyola University Med Center | Maywood | Illinois | 60153 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Horizon Oncology Research, Inc. | Lafayette | Indiana | 47905 | United States |
| James Graham Brown Cancer Center, University of Louisville | Louisville | Kentucky | 40202 | United States |
| New England Cancer Specialists | Scarborough | Maine | 04074 | United States |
| Anne Arundel Health System Research Instit-Annapolis Oncology Ctr | Annapolis | Maryland | 21401 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Spectrum Health Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| University of Minnesota. | Minneapolis | Minnesota | 55454 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | United States |
| Mercy Clinic Cancer & Hematology | Springfield | Missouri | 65804 | United States |
| St. John'S Mercy Medical Center; David C. Pratt Cancer Center | St Louis | Missouri | 63141 | United States |
| Dartmouth Hitchcock Med Center | Lebanon | New Hampshire | 03756 | United States |
| Hackensack Uni Medical Center; Northern Nj Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Cancer Inst. of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| Queens Medical Associates | Fresh Meadows | New York | 11366 | United States |
| Queens Hospital Center | Jamaica | New York | 11432 | United States |
| Arena Oncology Associates | Lake Success | New York | 11042 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Weill Medical College of Cornell Uni | New York | New York | 10065 | United States |
| Carolinas Hem-Oncology Assoc | Charlotte | North Carolina | 28203 | United States |
| Carolina Oncology Specialists, PA - Hickory | Hickory | North Carolina | 28602 | United States |
| Marion L. Shepard Cancer Center | Washington | North Carolina | 27889 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58102 | United States |
| Oncology Hematology Care - SCRI | Cincinnati | Ohio | 45242 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Charleston Oncology, P .A | Charleston | South Carolina | 29414 | United States |
| Medical University of SC (MUSC) | Charleston | South Carolina | 29425 | United States |
| South Carolina Oncology Associates - SCRI | Columbia | South Carolina | 29210 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| West Clinic | Germantown | Tennessee | 38138 | United States |
| Tennessee Onc., PLLC - SCRI | Nashville | Tennessee | 37203 | United States |
| Vanderbilt-Ingram Cancer Ctr | Nashville | Tennessee | 37232 | United States |
| The Don & Sybil Harrington Cancer Center; Department of Clinical Research | Amarillo | Texas | 79106 | United States |
| Uni of Texas Southwestern Medical Center | Dallas | Texas | 75390-9063 | United States |
| Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology | Houston | Texas | 77030 | United States |
| Northern Utah Associates | Ogden | Utah | 84403 | United States |
| The Providence Regional Medical Center Everett | Everett | Washington | 98201 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Fundación Investigar | Buenos Aires | 1025 | Argentina |
| Centro Medico San Roque | San Miguel de Tucumán | T4000IAK | Argentina |
| Mater Misericordiae Hospital; Chemotherapy Cottage | Sydney | New South Wales | 2060 | Australia |
| Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales | 2298 | Australia |
| Wesley Medical Centre; Clinic For Haematology and Oncology | Auchenflower | Queensland | 4066 | Australia |
| Royal Adelaide Hospital; Oncology | Adelaide | South Australia | 5000 | Australia |
| Peter Maccallum Cancer Institute; Medical Oncology | Melbourne | Victoria | 3000 | Australia |
| Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg | 5020 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie | Vienna | 1090 | Austria |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| Clinique Ste-Elisabeth | Namur | 5000 | Belgium |
| Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| University Clinical Centre of the Republic of Srpska | Banja Luka | 78000 | Bosnia and Herzegovina |
| Clinic of Oncology, University Clinical Center Sarajevo | Sarajevo | 71000 | Bosnia and Herzegovina |
| *X*Instituto Nacional do Cancer - INCA | Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
| Liga Norte Riograndense Contra O Câncer | Natal | Rio Grande do Norte | 59040150 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 90040-373 | Brazil |
| Clinica de Oncologia de Porto Alegre - CliniOnco | Porto Alegre | Rio Grande do Sul | 90430-090 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Clinica de Neoplasias Litoral | Itajaí | Santa Catarina | 88301-220 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Hospital Perola Byington | São Paulo | São Paulo | 01317-000 | Brazil |
| Cross Cancer Institute; Clinical Trials | Edmonton | Alberta | T6G 1Z2 | Canada |
| North York General Hospital | Toronto | Ontario | M2J 1V1 | Canada |
| Cuse - Centre Universitaire De Sante; Site Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY | Québec | G1S 4L8 | Canada |
| Clinica del Country | Bogotá | 11001 | Colombia |
| Instituto Colombiano Para El Avance De La Medicina: Icamedic | Bucaramanga | Colombia |
| Centro Medico Imbanaco | Cali | Colombia |
| Instituto Cancerologico de Nariño | Pasto | Colombia |
| Masarykuv onkologicky ustav | Brno | 656 53 | Czechia |
| Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | 779 00 | Czechia |
| Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika | Prague | 128 08 | Czechia |
| Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie | Prague | 180 00 | Czechia |
| Vejle Sygehus; Onkologisk Afdeling | Vejle | 7100 | Denmark |
| HOPITAL JEAN MINJOZ; Oncologie | Besançon | 25030 | France |
| Centre Jean Perrin; Hopital De Jour | Clermont-Ferrand | 63011 | France |
| Centre Oscar Lambret; Senologie | Lille | 59020 | France |
| Institut Paoli Calmettes; Oncologie Medicale | Marseille | 13273 | France |
| Institut régional du Cancer Montpellier | Montpellier | 34298 | France |
| Centre D'Oncologie de Gentilly; Oncology | Nancy | 54100 | France |
| Institut Curie; Oncologie Medicale | Paris | 75231 | France |
| Hopital Saint Louis; Service Onco Thoracique | Paris | 75475 | France |
| HOPITAL TENON; Cancerologie Medicale | Paris | 75970 | France |
| Chu La Miletrie; Radiotherapie | Poitiers | 86021 | France |
| Centre Rene Huguenin; ONCOLOGIE GENETIQUE | Saint-Cloud | 92210 | France |
| Institut de Cancerologie de La Loire; Radiotherapie | Saint-Priest-en-Jarez | 42271 | France |
| Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum | Essen | 45136 | Germany |
| Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie | Halle | 06120 | Germany |
| Facharztzentrum Eppendorf, Studien GbR | Hamburg | 20249 | Germany |
| MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer) | Hanover | 30177 | Germany |
| Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe | Magdeburg | 39108 | Germany |
| Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde | Mainz | 55131 | Germany |
| Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe | Minden | 32429 | Germany |
| Rotkreuzklinikum München; Frauenklinik | München | 80637 | Germany |
| Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie | Trier | 54290 | Germany |
| Alexandras General Hospital of Athens; Oncology Department | Athens | 115 28 | Greece |
| Univ General Hosp Heraklion; Medical Oncology | Heraklion | 711 10 | Greece |
| University Hospital of Larissa; Oncology | Larissa | Greece |
| Centro Oncológico Sixtino / Centro Oncológico SA | Guatemala City | 01010 | Guatemala |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Szent Margit Hospital; Dept. of Oncology | Budapest | 1032 | Hungary |
| Semmelweis Egyetem Onkologiai Központ | Budapest | 1083 | Hungary |
| Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika | Budapest | 1125 | Hungary |
| Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet | Pécs | 7623 | Hungary |
| Campus Universitario S.Venuta; Centro Oncologico T.Campanella | Catanzaro | Calabria | 88100 | Italy |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna | 47014 | Italy |
| A.O. Universitaria Policlinico Di Modena; Ematologia | Modena | Emilia-Romagna | 41124 | Italy |
| Arcispedale Santa Maria Nuova; Oncologia | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Ospedale Degli Infermi; Divisione Di Oncologia | Rimini | Emilia-Romagna | 47900 | Italy |
| Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Fondazione Salvatore Maugeri | Pavia | Lombardy | 27100 | Italy |
| IRCCS Istituto Clinico Humanitas; Oncologia | Rozzano (MI) | Lombardy | 20089 | Italy |
| Centro Catanese Di Oncologia; Oncologia Medica | Catania | Sicily | 95126 | Italy |
| Ospedale Papardo- Piemonte;Oncologia Medica | Messina | Sicily | 98158 | Italy |
| Ospedale Misericordia E Dolce; Oncologia Medica | Prato | Tuscany | 59100 | Italy |
| Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica | Perugia | Umbria | 06156 | Italy |
| Aichi Cancer Center Hospital, Breast Oncology | Aichi | 464-8681 | Japan |
| Natl Hosp Org Shikoku; Cancer Ctr, Surgery | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Cancer Center;Breast Oncology | Fukuoka | 811-1395 | Japan |
| Gifu University Hospital; Digestive Surgery | Gifu | 501-1194 | Japan |
| Hiroshima University Hospital; Breast Surgery | Hiroshima | 734-8551 | Japan |
| National Hospital Organization Hokkaido Cancer Center; Breast Surgery | Hokkaido | 003-0804 | Japan |
| Hyogo College Of Medicine; Breast And Endocrine Surgery | Hyōgo | 663-8501 | Japan |
| Hyogo Cancer Center; Breast Surgery | Hyōgo | 673-8558 | Japan |
| Kanazawa University Hospital; Breast Oncology | Ishikawa | 920-8641 | Japan |
| Sagara Hospital; Breast Surgery | Kagoshima | 892-0833 | Japan |
| Tokai University Hospital, Breast Surgery | Kanagawa | 259-1193 | Japan |
| Kumamoto University Hospital; Breast and Endocrine Surgery | Kumamoto | 860-8556 | Japan |
| Kumamoto City Hospital, Breast and Endocrine Surgery | Kumamoto | 862-8505 | Japan |
| Kyoto University Hospital; Breast Surgery | Kyoto | 606-8507 | Japan |
| Tohoku University Hospital; General Surgery | Miyagi | 980-8574 | Japan |
| Niigata Cancer Ctr Hospital; Breast Surgery | Niigata | 951-8566 | Japan |
| Iwate Med Univ School of Med; Surgery | Numakunai | 028-3695 | Japan |
| Kawasaki Medical School Hospital; Breast and Thyroid Surgery | Okayama | 701-0114 | Japan |
| National Hospital Organization Osaka National Hospital; Breast Surgery | Osaka | 540-0006 | Japan |
| Osaka University Hospital; Breast and Endocrine Surgery | Osaka | 565-0871 | Japan |
| Saitama Medical University International Medical Center; Medical Oncology | Saitama | 350-1298 | Japan |
| Saitama Cancer Center, Breast Oncology | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center; Breast Surgery | Shizuoka | 411-8777 | Japan |
| Shizuoka General Hospital; Breast Surgery | Shizuoka | 420-8527 | Japan |
| National Cancer Center Hospital; Medical Oncology | Tokyo | 104-0045 | Japan |
| Toranomon Hospital; Breast and Endocrine Surgery | Tokyo | 105-8470 | Japan |
| The Cancer Inst. Hosp. of JFCR; Breast Oncology Center | Tokyo | 135-8550 | Japan |
| Tokyo Medical Uni. Hospital; Breast Oncology | Tokyo | 160-0023 | Japan |
| Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy | Kuala Lumpur | FED. Territory of Kuala Lumpur | 59100 | Malaysia |
| Sunway Medical Centre | Kuala Selangor | Selangor | 46150 | Malaysia |
| Beacon International Specialist Centre | Petaling Jaya, Selangor | Selangor | 46050 | Malaysia |
| Centro de Investigacion; Clinica Del Pacifico | Acapulco de Juárez | Guerrero | 39670 | Mexico |
| Centro Universitario Contra El Cancer | Monterrey | Nuevo León | 64020 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | Oaxaca | 68000 | Mexico |
| Hospital Privado San Jose; Oncologia | Obregón | Sonora | 85000 | Mexico |
| Centenario Hospital Miguel Hidalgo | Aguascalientes | 20230 | Mexico |
| Centro Oncológico Estatal; ISSSEMYM Oncología | Toluca | 50180 | Mexico |
| Auckland city hospital; Auckland Regional Cancer Centre and Blood Service | Auckland | 1023 | New Zealand |
| Waikato Hospital; Regional Cancer Center | Hamilton | New Zealand |
| Private Health Organization Acibadem Sistina Hospital | Skopje | 1000 | North Macedonia |
| The Panama Clinic | Panama City | 0832-02723 | Panama |
| Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology | Arequipa | 04001 | Peru |
| Hospital Nacional Edgardo Rebagliati Martins; Oncologia | Lima | 11 | Peru |
| Unidad de Investigacion Oncologia Clinica ? Piura; Unidad de Oncología Clínica | Piura | 20011 | Peru |
| Cebu Cancer Institute; Perpetual Succour Hospital | Cebu City | 6000 | Philippines |
| Cardinal Santos Medical Center | San Juan City | 1502 | Philippines |
| Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii | Bydgoszcz | 85-796 | Poland |
| Medical University of Gdansk | Gdansk | 80-952 | Poland |
| Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii | Krakow | 31-115 | Poland |
| COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej | Lublin | 20-090 | Poland |
| Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon | Warsaw | 02-781 | Poland |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| Coltea Hospital; Oncology | Bucharest | Romania |
| Cluj Clinical County Hospital; Oncology Dept | Cluj-Napoca | 400006 | Romania |
| Prof. Dr. I. Chiricuta Institute of Oncology | Cluj-Napoca | 400015 | Romania |
| Moscow city oncology hospital; #62 of Moscow Healthcare Department | Moscow | Moscow Oblast | 143423 | Russia |
| Blokhin Cancer Research Center; Combined Treatment | Moskva | Moscow Oblast | 115478 | Russia |
| Ryazan State Medical University Named after I.P.Pavlov | Ryazan | Ryazan Oblast | 390026 | Russia |
| State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary | Pyatigorsk | Stavropol Kray | 357502 | Russia |
| Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan' | Tatarstan Republic | 420029 | Russia |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| SBI of Healthcare Samara Regional Clinical Oncology Dispensary | Samara | 443031 | Russia |
| SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary | Stavropol | 355045 | Russia |
| Tula Regional Oncology Dispensary | Tula | 300053 | Russia |
| GUZ Vladimir Regional Clinical Oncological Dispensary | Vladimir | 600009 | Russia |
| Seoul National University Bundang Hospital; Hematology Medical Oncology | Gyeonggi-do | 463-707 | South Korea |
| Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology | Seoul | 03080 | South Korea |
| Samsung Medical Centre; Division of Hematology/Oncology | Seoul | 135-710 | South Korea |
| Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology | Seoul | 138-736 | South Korea |
| Korea University Guro Hospital; Oncology | Seoul | 152-703 | South Korea |
| Hospital General Universitario de Elche; Servicio de Oncologia | Elche | Alicante | 03203 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Sant Andreu de la Barca | Barcelona | 08740 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología | A Coruña | 15006 | Spain |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaén | 23007 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Málaga | 29010 | Spain |
| Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | 46010 | Spain |
| Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling | Malmö | 200 25 | Sweden |
| Kantonsspital Baden; Medizinische Klinik, Onkologie | Baden | 5404 | Switzerland |
| Universitaetsspital Basel; Onkologie | Basel | 4031 | Switzerland |
| Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie | Chur | 7000 | Switzerland |
| Changhua Christian Hospital; Hematology-Oncology | Changhua | 500 | Taiwan |
| Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery | Kaohsiung City | 807 | Taiwan |
| National Taiwan Uni Hospital; Dept of Oncology | Taipei | 100 | Taiwan |
| Tri-Service General Hospital; Hematology and Oncology | Taipei | 114 | Taiwan |
| National Cancer Inst. | Bangkok | 10400 | Thailand |
| Rajavithi Hospital; Division of Medical Oncology | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Hospital; Internal Medicine | Chiang Mai | 50200 | Thailand |
| Songklanagarind Hospital; Department of Oncology | Songkhla | 90110 | Thailand |
| Oncology Consultants Limited | Nassau | 09311 | The Bahamas |
| Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology | Adana | 01230 | Turkey (Türkiye) |
| Cukurova Uni Faculty of Medicine; Medical Oncology | Adana | 01330 | Turkey (Türkiye) |
| Gazi Uni Medical Faculty Hospital; Oncology Dept | Ankara | 06500 | Turkey (Türkiye) |
| Ege Uni Medical Faculty Hospital; Oncology Dept | Izmir | 35100 | Turkey (Türkiye) |
| Bristol Haematology and Oncology centre | Bristol | BS2 8ED | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| Royal Cornwall Hospital; Dept of Clinical Oncology | Cornwall | TR1 3LQ | United Kingdom |
| The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit | Glasgow | G12 0YN | United Kingdom |
| Leicester Royal Infirmary; Dept. of Medical Oncology | Leicester | LE1 5WW | United Kingdom |
| Royal Free Hospital; Dept of Oncology | London | NW3 2QG | United Kingdom |
| Guys Hospital; Management Offices | London | SE1 9RT | United Kingdom |
| Royal Marsden Hospital; Dept of Med-Onc | London | SW3 6JJ | United Kingdom |
| Christie Hospital; Breast Cancer Research Office | Manchester | M20 4QL | United Kingdom |
| Nottingham City Hospital; Oncology | Nottingham | NG5 1PB | United Kingdom |
| Peterborough City Hospital; Oncology Ward | Peterborough | PE 3 9GZ | United Kingdom |
| Queen Alexandra Hospital, Portsmouth | Portsmouth | PO6 3LY | United Kingdom |
| Weston Park Hospital; Cancer Clinical Trials Centre | Sheffield | S10 2SJ | United Kingdom |
| Southampton General Hospital; Somers Cancer Research Building | Southampton | SO16 6YD | United Kingdom |
| Uni Hospital of North Staffordshire; Staffordshire Oncology Centre | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Royal Marsden Hospital; Dept of Medical Oncology | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Bighin C, Pronzato P, Del Mastro L. Trastuzumab emtansine in the treatment of HER-2-positive metastatic breast cancer patients. Future Oncol. 2013 Jul;9(7):955-7. doi: 10.2217/fon.13.74. |
| 22437872 | Derived | Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236. |
| FG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| FG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) Population: All participants randomized in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab + Taxane | Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy. |
| BG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| BG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| BG003 | 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 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment | Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | ITT Population. | Posted | Number | percentage of participants | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Progression-Free Survival (PFS) According to IRF Assessment | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method. | ITT Population. | Posted | Median | 95% Confidence Interval | months | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Died Prior to Clinical Cutoff | The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | ITT Population. | Posted | Number | percentage of participants | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) at Clinical Cutoff | OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method. | ITT Population. | Posted | Median | 95% Confidence Interval | months | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Death or Disease Progression According to Investigator Assessment | Tumor assessments were performed by the investigator according to RECIST version 1.1. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | ITT Population. | Posted | Number | percentage of participants | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | PFS According to Investigator Assessment | Tumor assessments were performed by the investigator according to RECIST version 1.1. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method. | ITT Population. | Posted | Median | 95% Confidence Interval | months | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | Percentage of Participants Experiencing Treatment Failure | Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. The percentage of participants with treatment failure was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | ITT Population. | Posted | Number | percentage of participants | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 |
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| Secondary | Time to Treatment Failure (TTF) | Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. TTF was defined as the time from randomization to treatment failure. Median TTF was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method. | ITT Population. | Posted | Median | 95% Confidence Interval | months | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 |
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| Secondary | One-Year Survival Rate | The percentage of participants alive at 1 year after randomization was estimated as the one-year survival rate using Kaplan-Meier analysis, and corresponding CIs were computed using Greenwood's estimate of the standard error. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage probability of being alive | From randomization until 1 year |
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| Secondary | Percentage of Participants With Grade ≥3 Adverse Events | Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival. Grade 5: Death. | Safety Population: All treated participants. Additionally, 2 participants randomized to trastuzumab+taxane received 3 cycles of trastuzumab emtansine and were included in trastuzumab emtansine+placebo arm. 6 participants randomized to trastuzumab emtansine+placebo received pertuzumab and were included in trastuzumab emtansine+pertuzumab arm. | Posted | Number | percentage of participants | Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose |
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| Secondary | Percentage of Participants Who Died at 2 Years | ITT Population | Posted | Number | percentage of participants | From randomization until 2 years |
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| Secondary | Overall Survival Truncated at 2 Years | Overall Survival truncated at 2 years was defined as the percentage of participants alive at 2 years. | ITT Population. | Posted | Number | percentage of participants | From randomization until 2 years |
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| Secondary | Percentage of Participants With Grade 5 Adverse Events | Adverse events were graded according to NCI CTCAE version 4.0. Grade 5 adverse events are those events which led to death. | Safety population | Posted | Number | percentage of participants | Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose) |
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| Secondary | Percentage of Participants With Grade 3-4 Laboratory Parameters | Laboratory results were graded according to NCI CTCAE version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival. | Safety population. Number of participants analyzed=participants with available data for the outcome. | Posted | Number | percentage of participants | Day 1, 8, and 15 of Cycle 1-3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014 |
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| Secondary | Percentage of Participants With Decline of ≥2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG performance status is a scale used to quantify cancer participants' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. | Safety population | Posted | Number | percentage of participants | Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months) |
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| Secondary | Hospitalization Days | Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. Reported values represent number of days admitted per participants. | Safety population. Number of participants analyzed=participants with hospitalization and data available for calculation of the parameter. | Posted | Median | Full Range | days | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 |
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| Secondary | Percentage of Participants With Hospitalization | Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. | Safety population | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 |
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| Secondary | Percentage of Participants With Objective Response According to IRF Assessment | Objective response was defined as having complete response (CR) or partial response (PR), assessed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the objective response rate [ORR]) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method. | ITT Population. Only participants with measurable disease at Baseline were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | Percentage of Participants With Objective Response According to Investigator Assessment | Objective response was defined as having CR or PR, assessed according to RECIST version 1.1, by investigator. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | Duration of Response According to IRF Assessment | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Duration of response was defined as the time from confirmed PR or CR to first documented disease progression or death from any cause. CR was defined as the disappearance of all target lesions and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. Median duration of response was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method. | ITT Population. Only participants achieving CR or PR were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient (20%) increase to qualify for disease progression. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR, PR, or SD was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. | Data were not analyzed. Protocol Amendment E removed this outcome measure as a secondary endpoint, because it was redundant to another prespecified secondary endpoint. | Posted | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score | The FACT-Taxane is a self-reported instrument which measures the health-related quality of life (HRQOL) of participants receiving taxane-containing chemotherapy. The FACT-TaxS consists of 16 items including 11 neurotoxicity-related questions and 5 additional questions assessing arthralgia, myalgia, and skin discoloration. Items are rated from 0 (not at all) to 4 (very much) and a total score is inversely derived. Scores may range from 0 to 64, with higher scores indicating fewer/no symptoms. A minimally clinically important difference in treatment-related symptoms was defined as a ≥5% decrease (ie, 3.2 points) in FACT-TaxS score from Baseline. The percentage of participants with treatment-related symptoms was calculated using following formula: [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method. | ITT Population (Protocol Amendment C Subpopulation): All randomized participants who entered the study after Protocol Amendment C. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose) |
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| Secondary | Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module | The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with nausea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100. | ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis. | Posted | Number | percentage of participants | At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2 |
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| Secondary | Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module | The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100. | ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis. | Posted | Number | percentage of participants | At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2 |
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| Secondary | Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score | The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. The percentage of participants with deterioration was calculated as [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100. | ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score. | Posted | Number | percentage of participants | Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose) |
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| Secondary | Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score | The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including PWB, SWB, EWB, FWB, and BCS. The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. Time to deterioration was defined as the time from Baseline until the first decrease in FACT-B TOI-PFB score. Median time to deterioration was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method. | ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score. | Posted | Median | 95% Confidence Interval | months | Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014 |
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| Secondary | Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score | The RSCL is a self-reported instrument which consists of 4 domains including physical symptom distress, psychological distress, activity level, and overall global life quality. Only the activity level scale was collected and assessed. Scores may range from 0 to 100, with higher scores indicating increased burden of disease. Mean RSCL activity scale score changes were calculated as [mean score at the assessment visit minus mean score at Baseline]. The higher the score, the higher the level of impairment or burden. | ITT Population. Here, 'n' signifies the number of participants with available data at baseline and Cycle 7 (Week 18). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Cycle 7 (Week 18) |
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| Secondary | Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score | The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect) | Number of participants analysed=participants from ITT population who were employed at baseline. Here, 'n' signifies the number of participants with available data at specified category. | Posted | Mean | 95% Confidence Interval | percent of work | Baseline, Cycle 7 (Week 18) |
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| Secondary | Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score | The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect). | Number of participants analysed=participants from ITT population who reported conduct of daily activities. Here, 'n' signifies the number of participants with available data at specified category. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Cycle 7 (Week 18) |
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| Secondary | Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. | ITT Population (High HER2 mRNA Subpopulation): All randomized participants with above-the-median HER2 mRNA expression (value greater than [>] 59.71). Only participants with measurable disease at Baseline were included in the analysis. | Posted | Number | percentage of participants | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. | ITT Population (Low HER2 mRNA Subpopulation): All randomized participants with below-the-median HER2 mRNA expression (value less than or equal to [≤] 59.71). Only participants with measurable disease at Baseline were included in the analysis. | Posted | Number | percentage of participants | Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | ITT Population (High HER2 mRNA Subpopulation). | Posted | Number | percentage of participants | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | PFS According to IRF Assessment Among Those With High HER2 mRNA Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis. | ITT Population (High HER2 mRNA Subpopulation). | Posted | Median | Full Range | months | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | ITT Population (Low HER2 mRNA Subpopulation). | Posted | Number | percentage of participants | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels | Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis. | ITT Population (Low HER2 mRNA Subpopulation). | Posted | Median | Full Range | months | Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) |
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| Secondary | Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels | The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | ITT Population (High HER2 mRNA Subpopulation). | Posted | Number | percentage of participants | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
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| Secondary | OS at Clinical Cutoff Among Those With High HER2 mRNA Levels | OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis. | ITT Population (High HER2 mRNA Subpopulation). | Posted | Median | Full Range | months | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
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| Secondary | Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels | The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100. | ITT Population (Low HER2 mRNA Subpopulation). | Posted | Number | percentage of participants | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
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| Secondary | OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels | OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis. Reported upper bound of confidence interval for "Trastuzumab Emtansine + Placebo" and confidence interval values for "Trastuzumab + Taxane" and "Trastuzumab Emtansine + Pertuzumab" are censored values. | ITT Population (Low HER2 mRNA Subpopulation). | Posted | Median | Full Range | months | Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) |
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Up to 70 months from randomization until clinical cutoff of 16 September 2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination).
Safety Population: All randomized participants who received at least one dose of study treatment and the participants were analyzed based on the treatment they actually received (N=353 in Trastuzumab + Taxane arm, N=361 in Trastuzumab Emtansine, Pertuzumab-placebo arm, N=366 in Trastuzumab emtansine + pertuzumab arm).
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 | Trastuzumab + Taxane | Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy. | 81 | 353 | 342 | 353 | ||
| EG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. | 86 | 361 | 352 | 361 | ||
| EG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. | 93 | 366 | 352 | 366 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Splenic artery aneurysm | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chorioretinitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Radiation retinopathy | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vascular dementia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Peau d'orange | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hepatic Fibrosis | Hepatobiliary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Anaphylactic Shock | Immune system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Anaphylactoid Reaction | Immune system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Appendicitis Perforated | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Catheter Site Infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal Injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Stomal Hernia | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Intracranial Tumour Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Device Breakage | Product Issues | MedDRA (19.0) | Non-systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cutaneous Lupus Erythematosus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypovolaemic Shock | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hepatic Haematoma | Hepatobiliary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Uncoded serious adverse event | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment | Per investigator, this serious adverse event was, "gamma nail implant broke (status after femur fracture)." |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Alanine aminotranseferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gamma- glutamyltranseferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (19.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.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 |
|---|---|
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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 |
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
| Trastuzumab Emtansine + Placebo |
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| Trastuzumab Emtansine + Placebo |
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
|
|
| OG002 |
| Trastuzumab Emtansine + Pertuzumab |
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG001 |
| Trastuzumab Emtansine + Placebo |
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
| Trastuzumab Emtansine + Placebo |
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
|
| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
|
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| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
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| OG001 | Trastuzumab Emtansine + Placebo | Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
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| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
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| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
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| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
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| OG002 | Trastuzumab Emtansine + Pertuzumab | Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination. |
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