A Study of Trastuzumab Emtansine (T-DM1) in Combination W... | NCT00934856 | Trialant
NCT00934856
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Apr 6, 2017Actual
Enrollment
98Actual
Phase
Phase 1Phase 2
Conditions
Breast Cancer
Interventions
Docetaxel
Pertuzumab
Trastuzumab emtansine
Countries
United States
France
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00934856
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BP22572
Secondary IDs
ID
Type
Description
Link
2009-010000-28
EudraCT Number
Brief Title
A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Participants With Advanced Breast Cancer
Official Title
An Open-Label, Multi-Center Phase I/II Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Feb 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2009Actual
Primary Completion Date
Oct 2013Actual
Completion Date
Oct 2013Actual
First Submitted Date
Jul 6, 2009
First Submission Date that Met QC Criteria
Jul 7, 2009
First Posted Date
Jul 8, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 20, 2017
Results First Submitted that Met QC Criteria
Feb 20, 2017
Results First Posted Date
Apr 6, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 20, 2017
Last Update Posted Date
Apr 6, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This is an open-label, multi-center, non-randomized study of the safety and tolerability of the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic breast cancer (MBC) and of T-DM1 plus docetaxel with or without pertuzumab, for the treatment of participants with locally advanced breast cancer (LABC). The study comprises an initial dose finding (feasibility) part to determine the maximum tolerated dose (MTD) of T-DM1 and docetaxel, followed by an extension part aiming to consolidate the safety and efficacy of the recommended docetaxel/T-DM1 combination regimen.
Participants with human epidermal growth factor receptor 2 (HER2)-positive MBC will receive docetaxel (Doc) 75 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 and T-DM1 2.4 milligrams per kilogram (mg/kg) IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 will be stopped and T-DM1 2.4 mg/kg will be continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
Participants with HER2-positive MBC will receive docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 will be stopped and T-DM1 2.4 mg/kg will be continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
Drug: Docetaxel
Drug: Trastuzumab emtansine
MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (same day)
Experimental
Participants with HER2-positive MBC will receive docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 will be stopped and T-DM1 2.4 mg/kg will be continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Docetaxel
Drug
Docetaxel will be administered on Day 1 of each 3-week cycle at a dose specified in the respective arms (as per summary of product characteristics [SmPC]).
LABC: T-DM1 + Doc (Doublet Regimen)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicity (DLT) - MBC and LABC Feasibility Population
DLTs included (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grading): Grade 4 thrombocytopenia, thrombocytopenia of any grade with concurrent hemorrhage or requiring blood platelet transfusion, or thrombocytopenia not recovered by Day 21 to at least 100,000/microliter (mcL); Grade 4 neutropenia lasting for more than 7 days; Febrile neutropenia; Grade greater than or equal to (>/=) 3 neurotoxicity in the form of peripheral neuropathy or peripheral neurotoxicity not improving to baseline or Grade less than or equal to (</=) 1 by Day 21; Any non-hematological toxicity of Grade >/= 3 except for alopecia, fever, and chills, not improving to baseline or Grade \
Cycle 1 (up to 21 days)
Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs) - MBC and LABC Population
An AE is any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Baseline up to 28 days after last dose for MBC participants and for LABC participants who could not undergo surgery, and up to 6 weeks post-surgery for LABC participants who underwent surgery (maximum up to approximately 3 years)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Progression-Free Survival (PFS) Event - MBC Population
PFS was defined as the time interval between the date of the start of treatment and the date of first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 (v1.0). For target lesions (TLs), PD was at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. For non-target lesions (NTLs), PD was the appearance of one or more new lesions and/or unequivocal progression of existing NTLs. Data for participants without PD or death was censored at the time of the last response assessment. Percentage of participants with PFS event was calculated as the (number of participants with PFS event [PD or death]) divided by (total number of participants), and then multiplied by 100.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (ECOG performance status of 2 will be allowed if only due to debilitating bone disease)
HER2-positive metastatic or locally advanced breast cancer
For MBC participants:
Documented metastatic or inoperable locally advanced (without meeting LABC criteria) disease, amenable for treatment with docetaxel
History of disease progression within 3 months prior to study entry
For LABC participants:
Newly diagnosed locally advanced breast cancer, Stage IIA-IIIC (American Joint Committee on Cancer [AJCC] staging system)
Exclusion Criteria:
Significant cardiac disease
Inadequate bone marrow, liver or renal function
For MBC participants:
Participants must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases
Brain metastases that are untreated, symptomatic or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastasis within 2 months of the first study treatment.
For LABC participants:
Clinically or radiologically detectable metastasis (M1 disease)
Participants for whom surgery as primary intent procedure is the best option to treat their disease
Participants must not have received any systemic or loco-regional anti-cancer therapy for the treatment of locally advanced disease
Martin M, Fumoleau P, Dewar JA, Albanell J, Limentani SA, Campone M, Chang JC, Patre M, Strasak A, de Haas SL, Xu J, Garcia-Saenz JA. Trastuzumab emtansine (T-DM1) plus docetaxel with or without pertuzumab in patients with HER2-positive locally advanced or metastatic breast cancer: results from a phase Ib/IIa study. Ann Oncol. 2016 Jul;27(7):1249-56. doi: 10.1093/annonc/mdw157. Epub 2016 Apr 6.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Overall 152 participants were screened, of which 98 participants were enrolled (25 participants with metastatic breast cancer [MBC] and 73 participants with locally advanced breast cancer [LABC]) and included in the study.
Feasibility part: Participants with human epidermal growth factor receptor 2 (HER2)-positive MBC received docetaxel (Doc) 75 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 and trastuzumab emtansine (T-DM1) 2.4 milligrams per kilogram (mg/kg) IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
Periods
Title
Milestones
Reasons Not Completed
Feasibility Part
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Docetaxel
Drug: Trastuzumab emtansine
MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (same day)
Experimental
Participants with HER2-positive MBC will receive docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 will be stopped and T-DM1 3.6 mg/kg will be continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
Drug: Docetaxel
Drug: Trastuzumab emtansine
LABC: T-DM1 + Doc (Doublet Regimen)
Experimental
Participants with HER2-positive LABC will receive T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment will be administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
Drug: Docetaxel
Drug: Trastuzumab emtansine
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)
Experimental
Participants with HER2-positive LABC will receive T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment will be administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
Pertuzumab at a loading dose of 840 mg IV infusion on Day 1 of Cycle 1 followed by maintenance dose of 420 mg IV infusion on Day 1 of each 3-week cycle.
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)
Trastuzumab emtansine
Drug
T-DM1 will be administered on Day 1 or Day 2 of each 3-week cycle at a dose specified in the respective arms.
Baseline until disease progression or death (up to approximately 3 years)
PFS - MBC Population
PFS was defined as the time interval between the date of the start of treatment and the date of first documentation of PD or death from any cause, whichever occurred first. Response was based on RECIST v1.0. For TLs, PD was at least a 20 % increase in the sum of LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. For NTLs, PD was the appearance of one or more new lesions and/or unequivocal progression of existing NTLs. Median PFS time was calculated using Kaplan-Meier estimates. Data for participants without PD or death was censored at the time of the last response assessment.
Baseline until disease progression or death (up to approximately 3 years)
Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) - MBC Population
BOR was defined as CR or PR recorded from baseline until disease progression/recurrence according to RECIST v1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of LDs of the TLs, taking as a reference the baseline (BL) sum of LDs. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with BOR rate was calculated as the (number of participants with CR or PR) divided by (total number of participants), and then multiplied by 100. The 95% confidence interval (Cl) was determined using the Pearson-Clopper method.
Baseline until disease progression or recurrence (up to approximately 3 years)
Percentage of Participants With Treatment Failure - MBC Population
Treatment failure was defined as the discontinuation of treatment for any reason, including the following qualifying events: PD, death from any cause, withdrawal from study treatment, or initiation of nonprotocol anti-cancer therapy. Percentage of participants with treatment failure was calculated as the (number of participants with treatment failure) divided by (total number of participants), and then multiplied by 100.
Baseline until end of treatment (up to 39.8 months)
Time to Treatment Failure (TTF) - MBC Population
TTF was defined as the time interval between the date of start of treatment and the date of PD, death from any cause, withdrawal from study treatment, or initiation of non-protocol anti-cancer therapy, whichever occurred first. Participants without an event at the time of the analysis were censored at the date of the last follow-up assessment. Median TTF was estimated using the Kaplan-Meier method.
Baseline until end of treatment (up to 39.8 months)
Percentage of Participants With CR or PR or Stable Disease (SD) for at Least 6 Months [Clinical Benefit Rate (CBR)] - MBC Population
CBR was defined as percentage of participants experiencing SD of at least 6 months from the start of treatment plus CR or PR according to the RECIST v1.0 criteria. For TLs: CR- disappearance of all TLs. PR- at least 30% decrease in the sum of LDs of the TLs, taking as a reference the BL sum of LDs. PD- at least 20% increase in the sum of LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. SD- neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For NTLs: CR- disappearance of all NTLs and normalization of tumor marker levels. SD- persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Percentage of participants= number of participants with CR/PR/SD divided by total number of participants, and then multiplied by 100. 95% CI was determined using the Pearson-Clopper method.
Baseline until disease progression, recurrence or death (up to approximately 3 years)
Duration of Response - MBC Population
Duration of response was calculated for participants with CR or PR based on the RECIST v1.0 criteria. Duration of response was defined as the time interval between the date the CR or PR was first recorded and the date on which PD was first noted or date of death, whichever occurred first. Participants with no documented PD after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively. Median duration of response was estimated using the Kaplan-Meier method.
Baseline until disease progression, recurrence or death (up to approximately 3 years)
Percentage of Participants With Pathological CR (pCR) - LABC Population
The pCR was defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants and lymph nodes after surgery following primary systemic therapy.
Within 6 weeks of post-surgery (up to approximately 3 years)
Percentage of Participants With a BOR of CR or PR - LABC Population
BOR was defined as CR or PR recorded from baseline until disease progression/recurrence according to RECIST v1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of LDs of the TLs, taking as a reference the baseline (BL) sum of LDs. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with BOR rate was calculated as the (number of participants with CR or PR) divided by (total number of participants), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.
Baseline until disease progression, recurrence or death (up to approximately 3 years)
Number of Participants With Anti-Therapeutic Antibody (ATA) Response to Trastuzumab - MBC and LABC Population
Number of participants with ATA response was reported. Data for this outcome measure was planned to be reported for overall MBC and LABC participants and not by individual treatment arms.
Baseline (Day 1 of Cycle 1), Post baseline (at first follow-up visit [28 days after last dose of study drug][up to approximately 145 weeks])
Maximum Observed Concentration (Cmax) of Serum Trastuzumab Emtansine
Cycle 1: pre-dose (Hour [Hr] 0), 0.25, 4 hrs post end of infusion (EOI) of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
Apparent Terminal Half-Life (t1/2) of Serum Trastuzumab Emtansine
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Serum Trastuzumab Emtansine
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
Clearance (CL) of Serum Trastuzumab Emtansine
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
Volume of Distribution at Steady State (Vss) of Serum Trastuzumab Emtansine
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
Cmax of Total Serum Trastuzumab
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
t1/2 of Total Serum Trastuzumab
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
AUCinf of Total Serum Trastuzumab
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
CL of Total Serum Trastuzumab
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
Vss of Total Serum Trastuzumab
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
Cmax of Plasma N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1)
DM1 is the metabolite of trastuzumab emtansine.
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
t1/2 of Plasma DM1
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
AUCinf of Plasma DM1
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
Cmax of Plasma Docetaxel
Docetaxel infusion duration = 1 hr (as per summary of product characteristics [SmPC])
Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)
t1/2 of Plasma Docetaxel
Docetaxel infusion duration = 1 hr (as per SmPC)
Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)
AUCinf of Plasma Docetaxel
Docetaxel infusion duration = 1 hr (as per SmPC)
Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)
CL of Plasma Docetaxel
Docetaxel infusion duration = 1 hr (as per SmPC)
Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)
Vss of Plasma Docetaxel
Docetaxel infusion duration = 1 hr (as per SmPC)
Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)
Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
FG002
MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)
Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
FG003
MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)
Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
FG004
LABC: T-DM1 + Doc (Doublet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
FG005
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
FG0006 subjects
FG0016 subjects
FG0023 subjects
FG0036 subjects
FG00412 subjects
FG0059 subjects
COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG00412 subjects
FG0056 subjects
NOT COMPLETED
FG0005 subjects
FG0015 subjects
FG0023 subjects
FG0035 subjects
FG0040 subjects
FG0053 subjects
Type
Comment
Reasons
Progressive disease
FG0004 subjects
FG0014 subjects
FG0022 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
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FG0031 subjects
FG004
Extension Part
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjectsNew participants were enrolled in the extension part.
FG00428 subjectsNew participants were enrolled in the extension part.
FG00524 subjectsNew participants were enrolled in the extension part.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All participants who received at least one dose of study medication were included.
Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
BG002
MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)
Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
BG003
MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)
Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
BG004
LABC: T-DM1 + Doc (Doublet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
BG005
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0023
BG00310
BG00440
BG00533
BG00698
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00043± 7.16
BG00150.7± 4.84
BG00257± 12.12
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0016
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicity (DLT) - MBC and LABC Feasibility Population
DLTs included (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grading): Grade 4 thrombocytopenia, thrombocytopenia of any grade with concurrent hemorrhage or requiring blood platelet transfusion, or thrombocytopenia not recovered by Day 21 to at least 100,000/microliter (mcL); Grade 4 neutropenia lasting for more than 7 days; Febrile neutropenia; Grade greater than or equal to (>/=) 3 neurotoxicity in the form of peripheral neuropathy or peripheral neurotoxicity not improving to baseline or Grade less than or equal to (</=) 1 by Day 21; Any non-hematological toxicity of Grade >/= 3 except for alopecia, fever, and chills, not improving to baseline or Grade \
MBC and LABC feasibility population: All participants who received at least one dose of study medication and included in the feasibility part of the study.
Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
OG002
MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)
Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
OG003
MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)
Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
OG004
LABC: T-DM1 + Doc (Doublet Regimen)
Units
Counts
Participants
OG0006
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0020
OG003
Primary
Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs) - MBC and LABC Population
An AE is any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
All participants who received at least one dose of study medication were included.
Posted
Number
percentage of participants
Baseline up to 28 days after last dose for MBC participants and for LABC participants who could not undergo surgery, and up to 6 weeks post-surgery for LABC participants who underwent surgery (maximum up to approximately 3 years)
Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
Percentage of Participants With Progression-Free Survival (PFS) Event - MBC Population
PFS was defined as the time interval between the date of the start of treatment and the date of first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 (v1.0). For target lesions (TLs), PD was at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. For non-target lesions (NTLs), PD was the appearance of one or more new lesions and/or unequivocal progression of existing NTLs. Data for participants without PD or death was censored at the time of the last response assessment. Percentage of participants with PFS event was calculated as the (number of participants with PFS event [PD or death]) divided by (total number of participants), and then multiplied by 100.
MBC population: All participants with MBC who received at least one dose of study medication were included.
Posted
Number
percentage of participants
Baseline until disease progression or death (up to approximately 3 years)
ID
Title
Description
OG000
Overall MBC Participants
Participants with MBC who were enrolled in the study and who received at least one dose of study medication
Units
Counts
Secondary
PFS - MBC Population
PFS was defined as the time interval between the date of the start of treatment and the date of first documentation of PD or death from any cause, whichever occurred first. Response was based on RECIST v1.0. For TLs, PD was at least a 20 % increase in the sum of LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. For NTLs, PD was the appearance of one or more new lesions and/or unequivocal progression of existing NTLs. Median PFS time was calculated using Kaplan-Meier estimates. Data for participants without PD or death was censored at the time of the last response assessment.
MBC population
Posted
Median
Full Range
months
Baseline until disease progression or death (up to approximately 3 years)
ID
Title
Description
OG000
Overall MBC Participants
Participants with MBC who were enrolled in the study and who received at least one dose of study medication
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) - MBC Population
BOR was defined as CR or PR recorded from baseline until disease progression/recurrence according to RECIST v1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of LDs of the TLs, taking as a reference the baseline (BL) sum of LDs. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with BOR rate was calculated as the (number of participants with CR or PR) divided by (total number of participants), and then multiplied by 100. The 95% confidence interval (Cl) was determined using the Pearson-Clopper method.
MBC population
Posted
Number
95% Confidence Interval
percentage of participants
Baseline until disease progression or recurrence (up to approximately 3 years)
ID
Title
Description
OG000
Overall MBC Participants
Participants with MBC who were enrolled in the study and who received at least one dose of study medication
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Treatment Failure - MBC Population
Treatment failure was defined as the discontinuation of treatment for any reason, including the following qualifying events: PD, death from any cause, withdrawal from study treatment, or initiation of nonprotocol anti-cancer therapy. Percentage of participants with treatment failure was calculated as the (number of participants with treatment failure) divided by (total number of participants), and then multiplied by 100.
MBC population
Posted
Number
percentage of participants
Baseline until end of treatment (up to 39.8 months)
ID
Title
Description
OG000
Overall MBC Participants
Participants with MBC who were enrolled in the study and who received at least one dose of study medication
Units
Counts
Participants
OG000
Secondary
Time to Treatment Failure (TTF) - MBC Population
TTF was defined as the time interval between the date of start of treatment and the date of PD, death from any cause, withdrawal from study treatment, or initiation of non-protocol anti-cancer therapy, whichever occurred first. Participants without an event at the time of the analysis were censored at the date of the last follow-up assessment. Median TTF was estimated using the Kaplan-Meier method.
MBC population
Posted
Median
Full Range
months
Baseline until end of treatment (up to 39.8 months)
ID
Title
Description
OG000
Overall MBC Participants
Participants with MBC who were enrolled in the study and who received at least one dose of study medication
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With CR or PR or Stable Disease (SD) for at Least 6 Months [Clinical Benefit Rate (CBR)] - MBC Population
CBR was defined as percentage of participants experiencing SD of at least 6 months from the start of treatment plus CR or PR according to the RECIST v1.0 criteria. For TLs: CR- disappearance of all TLs. PR- at least 30% decrease in the sum of LDs of the TLs, taking as a reference the BL sum of LDs. PD- at least 20% increase in the sum of LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. SD- neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For NTLs: CR- disappearance of all NTLs and normalization of tumor marker levels. SD- persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Percentage of participants= number of participants with CR/PR/SD divided by total number of participants, and then multiplied by 100. 95% CI was determined using the Pearson-Clopper method.
MBC population
Posted
Number
95% Confidence Interval
percentage of participants
Baseline until disease progression, recurrence or death (up to approximately 3 years)
ID
Title
Description
OG000
Overall MBC Participants
Participants with MBC who were enrolled in the study and who received at least one dose of study medication
Units
Counts
Secondary
Duration of Response - MBC Population
Duration of response was calculated for participants with CR or PR based on the RECIST v1.0 criteria. Duration of response was defined as the time interval between the date the CR or PR was first recorded and the date on which PD was first noted or date of death, whichever occurred first. Participants with no documented PD after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively. Median duration of response was estimated using the Kaplan-Meier method.
MBC population
Posted
Median
Full Range
months
Baseline until disease progression, recurrence or death (up to approximately 3 years)
ID
Title
Description
OG000
Overall MBC Participants
Participants with MBC who were enrolled in the study and who received at least one dose of study medication
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Pathological CR (pCR) - LABC Population
The pCR was defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants and lymph nodes after surgery following primary systemic therapy.
LABC population: All participants with LABC who received at least one dose of study medication.
Posted
Number
95% Confidence Interval
percentage of participants
Within 6 weeks of post-surgery (up to approximately 3 years)
ID
Title
Description
OG000
LABC: T-DM1 + Doc (Doublet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
OG001
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
Secondary
Percentage of Participants With a BOR of CR or PR - LABC Population
BOR was defined as CR or PR recorded from baseline until disease progression/recurrence according to RECIST v1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of LDs of the TLs, taking as a reference the baseline (BL) sum of LDs. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with BOR rate was calculated as the (number of participants with CR or PR) divided by (total number of participants), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.
LABC population
Posted
Number
95% Confidence Interval
percentage of participants
Baseline until disease progression, recurrence or death (up to approximately 3 years)
ID
Title
Description
OG000
LABC: T-DM1 + Doc (Doublet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
OG001
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
Secondary
Number of Participants With Anti-Therapeutic Antibody (ATA) Response to Trastuzumab - MBC and LABC Population
Number of participants with ATA response was reported. Data for this outcome measure was planned to be reported for overall MBC and LABC participants and not by individual treatment arms.
All participants who received at least one dose of study medication were included. Here, number analyzed=participants evaluable for ATA at specified time-point.
Posted
Number
participants
Baseline (Day 1 of Cycle 1), Post baseline (at first follow-up visit [28 days after last dose of study drug][up to approximately 145 weeks])
ID
Title
Description
OG000
Overall MBC and LABC Participants
All enrolled participants who received at least one dose of study medication
Units
Counts
Participants
OG000
Secondary
Maximum Observed Concentration (Cmax) of Serum Trastuzumab Emtansine
Pharmacokinetic (PK) analysis population: PK-evaluable participants were defined as participants who received at least one dose of T-DM1 or docetaxel with at least one post-dose concentration data point. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
micrograms per milliliter (mcg/mL)
Cycle 1: pre-dose (Hour [Hr] 0), 0.25, 4 hrs post end of infusion (EOI) of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Secondary
Apparent Terminal Half-Life (t1/2) of Serum Trastuzumab Emtansine
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
days
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Serum Trastuzumab Emtansine
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
day*mcg/mL
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
Clearance (CL) of Serum Trastuzumab Emtansine
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
milliliters/day/kilogram (mL/day/kg)
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
Volume of Distribution at Steady State (Vss) of Serum Trastuzumab Emtansine
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
mL/kg
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
Cmax of Total Serum Trastuzumab
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
mcg/mL
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
t1/2 of Total Serum Trastuzumab
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
days
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
AUCinf of Total Serum Trastuzumab
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
day*mcg/mL
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
CL of Total Serum Trastuzumab
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
mL/day/kg
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
Vss of Total Serum Trastuzumab
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
mL/kg
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
Cmax of Plasma N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1)
DM1 is the metabolite of trastuzumab emtansine.
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Secondary
t1/2 of Plasma DM1
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
days
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
AUCinf of Plasma DM1
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
day*ng/mL
Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)
ID
Title
Description
OG000
MBC: T-DM1 2.4 mg/kg
All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
OG001
MBC: T-DM1 3.6 mg/kg
All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
OG002
LABC: T-DM1 3.6 mg/kg
All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
Units
Counts
Participants
Secondary
Cmax of Plasma Docetaxel
Docetaxel infusion duration = 1 hr (as per summary of product characteristics [SmPC])
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
ng/mL
Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)
ID
Title
Description
OG000
MBC: Docetaxel 75 mg/m^2
All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
OG001
MBC: Docetaxel 60 mg/m^2
All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
OG002
LABC: Docetaxel 60 mg/m^2
All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
OG003
LABC: Docetaxel 75 mg/m^2
Secondary
t1/2 of Plasma Docetaxel
Docetaxel infusion duration = 1 hr (as per SmPC)
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
hours (hr)
Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)
ID
Title
Description
OG000
MBC: Docetaxel 75 mg/m^2
All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
OG001
MBC: Docetaxel 60 mg/m^2
All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
OG002
LABC: Docetaxel 60 mg/m^2
All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
OG003
LABC: Docetaxel 75 mg/m^2
All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
Secondary
AUCinf of Plasma Docetaxel
Docetaxel infusion duration = 1 hr (as per SmPC)
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
hr*ng/mL
Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)
ID
Title
Description
OG000
MBC: Docetaxel 75 mg/m^2
All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
OG001
MBC: Docetaxel 60 mg/m^2
All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
OG002
LABC: Docetaxel 60 mg/m^2
All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
OG003
LABC: Docetaxel 75 mg/m^2
All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
Secondary
CL of Plasma Docetaxel
Docetaxel infusion duration = 1 hr (as per SmPC)
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
liters/hour/square meter (L/hr/m^2)
Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)
ID
Title
Description
OG000
MBC: Docetaxel 75 mg/m^2
All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
OG001
MBC: Docetaxel 60 mg/m^2
All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
OG002
LABC: Docetaxel 60 mg/m^2
All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
OG003
LABC: Docetaxel 75 mg/m^2
All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
Secondary
Vss of Plasma Docetaxel
Docetaxel infusion duration = 1 hr (as per SmPC)
PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.
Posted
Mean
Standard Deviation
liters per square meter (L/m^2)
Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)
ID
Title
Description
OG000
MBC: Docetaxel 75 mg/m^2
All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
OG001
MBC: Docetaxel 60 mg/m^2
All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
OG002
LABC: Docetaxel 60 mg/m^2
All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
OG003
LABC: Docetaxel 75 mg/m^2
All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
Time Frame
Baseline up to 28 days after last dose for MBC participants and for LABC participants who could not undergo surgery, and up to 6 weeks post-surgery for LABC participants who underwent surgery (maximum up to approximately 3 years)
Description
All participants who received at least one dose of study medication were included.
Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
2
6
6
6
EG002
MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)
Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
2
3
3
3
EG003
MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)
Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
4
10
10
10
EG004
LABC: T-DM1 + Doc (Doublet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
9
40
40
40
EG005
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
9
33
33
33
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Haematoma
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG0031 affected10 at risk
EG0040 affected40 at risk
EG0050 affected33 at risk
Pyrexia
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Thrombosis in device
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Melanoderma
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dermatitis exfoliative
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dermatomyositis
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Viral infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Anal abscess
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Device deployment issue
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hot flush
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG0030 affected10 at risk
EG0045 affected40 at risk
EG0050 affected33 at risk
Flushing
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pallor
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Varicose vein
Vascular disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Tooth repair
Surgical and medical procedures
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0006 affected6 at risk
EG0015 affected6 at risk
EG0021 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0015 affected6 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Mucosal dryness
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Feeling hot
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Axillary pain
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Local swelling
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Temperature intolerance
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Temperature regulation disorder
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Thrombosis in device
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Vaccination site reaction
General disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Recall phenomenon
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Tooth avulsion
Injury, poisoning and procedural complications
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Body temperature increased
Investigations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Systolic dysfunction
Cardiac disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0015 affected6 at risk
EG0021 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0022 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Nasal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Suffocation feeling
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0006 affected6 at risk
EG0015 affected6 at risk
EG0021 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0004 affected6 at risk
EG0014 affected6 at risk
EG0020 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0005 affected6 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0005 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Aphonia
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Migraine
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Blepharospasm
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Conjunctival oedema
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Eye disorder
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Eye pain
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Eyelids pruritus
Eye disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0015 affected6 at risk
EG0021 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0013 affected6 at risk
EG0021 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0023 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0022 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0014 affected6 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Aphthous Stomatitis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Breath odour
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Epulis
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Tooth loss
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pyelocaliectasis
Renal and urinary disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0004 affected6 at risk
EG0014 affected6 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Madarosis
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Skin toxicity
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0004 affected6 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0004 affected6 at risk
EG0014 affected6 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Eye infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Genital herpes
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Mastitis
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Wound infection
Infections and infestations
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Allodynia
Nervous system disorders
MedDRA (16.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Communications
Hoffmann-La Roche
800-821-8590
global-roche-genentech-trials@gene.com
ID
Term
D001943
Breast Neoplasms
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077143
Docetaxel
C485206
pertuzumab
D000080044
Ado-Trastuzumab Emtansine
Ancestor Terms
ID
Term
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
D008453
Maytansine
D018942
Macrolides
D007783
Lactones
D047029
Lactams, Macrocyclic
D047028
Macrocyclic Compounds
D011083
Polycyclic Compounds
D000068878
Trastuzumab
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
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0052 subjects
0 subjects
FG0051 subjects
24 subjects
FG00519 subjects
4 subjects
FG0055 subjects
1 subjects
FG0044 subjects
FG0054 subjects
Progressive disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Non-compliance with drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
48
± 9.39
BG00448.6± 9.73
BG00554.2± 11.43
BG00650.4± 10.39
3
BG00310
BG00440
BG00533
BG00698
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
OG005
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)
Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
6
OG00412
OG0059
1
OG0042
OG0052
Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
OG002
MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)
Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
OG003
MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)
Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
OG004
LABC: T-DM1 + Doc (Doublet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
OG005
LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)
Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
Units
Counts
Participants
OG0006
OG0016
OG0023
OG00310
OG00440
OG00533
Title
Denominators
Categories
AEs
Title
Measurements
OG000100
OG001100
OG002100
OG003100
OG004100
OG005100
SAEs
Title
Measurements
OG00033.3
OG00133.3
OG00266.7
OG003
Participants
OG00025
Title
Denominators
Categories
Title
Measurements
OG00060.0
25
Title
Denominators
Categories
Title
Measurements
OG00013.8(1.6 to 33.5)
25
Title
Denominators
Categories
Title
Measurements
OG00080.0(59.3 to 93.2)
25
Title
Denominators
Categories
Title
Measurements
OG00064.0
25
Title
Denominators
Categories
Title
Measurements
OG00013.8(1.4 to 39.8)
Participants
OG00025
Title
Denominators
Categories
Title
Measurements
OG00092.0(74.0 to 99.0)
25
Title
Denominators
Categories
Title
Measurements
OG00012.4(3.9 to 32.7)
Units
Counts
Participants
OG00040
OG00133
Title
Denominators
Categories
Title
Measurements
OG00060.0(43.3 to 75.1)
OG00160.6(42.1 to 77.1)
Units
Counts
Participants
OG00040
OG00133
Title
Denominators
Categories
Title
Measurements
OG00070.0(53.5 to 83.4)
OG00151.5(33.5 to 69.2)
98
Title
Denominators
Categories
Baseline
ParticipantsOG00089
Title
Measurements
OG0003
Post-baseline
ParticipantsOG00079
Title
Measurements
OG0003
Participants
OG00015
OG00110
OG00273
Title
Denominators
Categories
Cycle 1
ParticipantsOG00015
ParticipantsOG00110
ParticipantsOG00273
Title
Measurements
OG00078.6± 16.6
OG00176.2± 36.4
OG00285.7± 15.3
Cycle 2
ParticipantsOG00014
ParticipantsOG0019
ParticipantsOG00267
Title
Measurements
OG000
OG00015
OG0018
OG00272
Title
Denominators
Categories
Cycle 1
ParticipantsOG00015
ParticipantsOG0017
ParticipantsOG00272
Title
Measurements
OG0002.79± 0.637
OG0013.45± 0.779
OG0023.46± 0.558
Cycle 2
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00263
Title
Measurements
OG000
OG00015
OG0018
OG00272
Title
Denominators
Categories
Cycle 1
ParticipantsOG00015
ParticipantsOG0017
ParticipantsOG00272
Title
Measurements
OG000396± 124
OG001447± 144
OG002442± 90.7
Cycle 2
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00263
Title
Measurements
OG000
OG00015
OG0018
OG00272
Title
Denominators
Categories
Cycle 1
ParticipantsOG00015
ParticipantsOG0017
ParticipantsOG00272
Title
Measurements
OG0008.94± 12
OG0018.87± 2.96
OG0028.48± 1.86
Cycle 2
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00263
Title
Measurements
OG000
OG00015
OG0018
OG00272
Title
Denominators
Categories
Cycle 1
ParticipantsOG00015
ParticipantsOG0017
ParticipantsOG00272
Title
Measurements
OG00022.1± 6.74
OG00133.2± 9.13
OG00233.2± 8.36
Cycle 2
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00263
Title
Measurements
OG000
OG00015
OG00110
OG00273
Title
Denominators
Categories
Cycle 1
ParticipantsOG00015
ParticipantsOG00110
ParticipantsOG00273
Title
Measurements
OG00088.7± 22.6
OG00189.2± 47.4
OG002120± 46.6
Cycle 2
ParticipantsOG00014
ParticipantsOG0019
ParticipantsOG00267
Title
Measurements
OG000
OG00015
OG0018
OG00273
Title
Denominators
Categories
Cycle 1
ParticipantsOG00015
ParticipantsOG0017
ParticipantsOG00273
Title
Measurements
OG0006.44± 2.6
OG0016.38± 1.41
OG0028.12± 4.2
Cycle 2
ParticipantsOG00013
ParticipantsOG0018
ParticipantsOG00262
Title
Measurements
OG000
OG00015
OG0018
OG00273
Title
Denominators
Categories
Cycle 1
ParticipantsOG00015
ParticipantsOG0017
ParticipantsOG00273
Title
Measurements
OG000785± 429
OG001707± 201
OG0021210± 856
Cycle 2
ParticipantsOG00013
ParticipantsOG0018
ParticipantsOG00262
Title
Measurements
OG000
OG00015
OG0018
OG00273
Title
Denominators
Categories
Cycle 1
ParticipantsOG00015
ParticipantsOG0017
ParticipantsOG00273
Title
Measurements
OG0006.78± 13.3
OG0015.45± 1.46
OG0024.22± 2.13
Cycle 2
ParticipantsOG00013
ParticipantsOG0018
ParticipantsOG00262
Title
Measurements
OG000
OG00015
OG0018
OG00273
Title
Denominators
Categories
Cycle 1
ParticipantsOG00015
ParticipantsOG0017
ParticipantsOG00273
Title
Measurements
OG00027± 7.16
OG00141.3± 9.24
OG00236.5± 12.7
Cycle 2
ParticipantsOG00013
ParticipantsOG0018
ParticipantsOG00262
Title
Measurements
OG000
Participants
OG00013
OG0019
OG00273
Title
Denominators
Categories
Cycle 1
ParticipantsOG00013
ParticipantsOG0019
ParticipantsOG00273
Title
Measurements
OG0003.55± 1.6
OG0013.42± 0.944
OG0024.51± 1.38
Cycle 2
ParticipantsOG00013
ParticipantsOG0019
ParticipantsOG00267
Title
Measurements
OG000
OG00012
OG0017
OG00268
Title
Denominators
Categories
Cycle 1
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG00268
Title
Measurements
OG0001.12± 0.702
OG0011.2± 0.985
OG0021.87± 1.63
Cycle 2
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00231
Title
Measurements
OG000
OG00012
OG0017
OG00268
Title
Denominators
Categories
Cycle 1
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG00268
Title
Measurements
OG0005.72± 5.16
OG0015.01± 2.54
OG0029.38± 9.33
Cycle 2
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00231
Title
Measurements
OG000
All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
OG004
LABC: Docetaxel 100 mg/m^2
All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
Units
Counts
Participants
OG0006
OG00119
OG00214
OG00336
OG00422
Title
Denominators
Categories
Cycle 1
ParticipantsOG0006
ParticipantsOG00119
ParticipantsOG00214
ParticipantsOG00336
ParticipantsOG00422
Title
Measurements
OG000500± 216
OG0011300± 829
OG0021470± 551
OG003
Cycle 2
ParticipantsOG0006
ParticipantsOG00117
ParticipantsOG00212
ParticipantsOG00335
OG004
LABC: Docetaxel 100 mg/m^2
All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
Units
Counts
Participants
OG0006
OG00119
OG00214
OG00336
OG00422
Title
Denominators
Categories
Cycle 1
ParticipantsOG0006
ParticipantsOG00119
ParticipantsOG00214
ParticipantsOG00336
ParticipantsOG00422
Title
Measurements
OG0006.83± 4.22
OG0015.17± 4.02
OG0024.25± 5.61
OG003
Cycle 2
ParticipantsOG0006
ParticipantsOG00117
ParticipantsOG00212
ParticipantsOG00335
OG004
LABC: Docetaxel 100 mg/m^2
All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
Units
Counts
Participants
OG0006
OG00119
OG00214
OG00336
OG00422
Title
Denominators
Categories
Cycle 1
ParticipantsOG0006
ParticipantsOG00119
ParticipantsOG00214
ParticipantsOG00336
ParticipantsOG00422
Title
Measurements
OG0001050± 475
OG0011560± 874
OG0021540± 421
OG003
Cycle 2
ParticipantsOG0006
ParticipantsOG00117
ParticipantsOG00212
ParticipantsOG00335
OG004
LABC: Docetaxel 100 mg/m^2
All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
Units
Counts
Participants
OG0006
OG00119
OG00214
OG00336
OG00422
Title
Denominators
Categories
Cycle 1
ParticipantsOG0006
ParticipantsOG00119
ParticipantsOG00214
ParticipantsOG00336
ParticipantsOG00422
Title
Measurements
OG00082.2± 32.6
OG00158.3± 40.9
OG00242.8± 16.4
OG003
Cycle 2
ParticipantsOG0006
ParticipantsOG00117
ParticipantsOG00212
ParticipantsOG00335
OG004
LABC: Docetaxel 100 mg/m^2
All LABC participants who received docetaxel 100 mg/m^2 IV infusion.