Trial Outcomes & Findings for A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease (NCT NCT00679341)
NCT ID: NCT00679341
Last Updated: 2014-01-09
Results Overview
PFS was defined as the time from randomization (R) to first documented investigator-assessed radiographic or clinical disease progression (PD) or death due to any cause, whichever occurred first. For target lesions (TL), PD was defined as at least a 20% increase in the sum of the longest diameter (SLD) of TLs, taking as reference the SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Data for patients without PD or death were censored at the last date of tumor assessment prior to crossover (or, if no tumor assessment was performed after Baseline, at the R date +1 day). Data for patients who were lost to follow-up were censored at the last date of tumor assessment prior to crossover at which the patient was known to be progression free. Data for patients with no post-baseline tumor assessment were censored at the R date +1 day.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
137 participants
Primary outcome timeframe
Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)
Results posted on
2014-01-09
Participant Flow
Participant milestones
| Measure |
Trastuzumab Emtansine
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
70
|
|
Overall Study
COMPLETED
|
14
|
19
|
|
Overall Study
NOT COMPLETED
|
53
|
51
|
Reasons for withdrawal
| Measure |
Trastuzumab Emtansine
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Overall Study
Disease progression
|
42
|
36
|
|
Overall Study
Adverse Event
|
5
|
6
|
|
Overall Study
Subject/guardian decision to discontinue
|
3
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Not treated
|
0
|
2
|
|
Overall Study
Physician/patient decision to withdraw
|
0
|
6
|
Baseline Characteristics
A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
Baseline characteristics by cohort
| Measure |
Trastuzumab Emtansine
n=67 Participants
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
n=70 Participants
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)Population: Intent-to-treat population: All randomized patients.
PFS was defined as the time from randomization (R) to first documented investigator-assessed radiographic or clinical disease progression (PD) or death due to any cause, whichever occurred first. For target lesions (TL), PD was defined as at least a 20% increase in the sum of the longest diameter (SLD) of TLs, taking as reference the SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Data for patients without PD or death were censored at the last date of tumor assessment prior to crossover (or, if no tumor assessment was performed after Baseline, at the R date +1 day). Data for patients who were lost to follow-up were censored at the last date of tumor assessment prior to crossover at which the patient was known to be progression free. Data for patients with no post-baseline tumor assessment were censored at the R date +1 day.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=67 Participants
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
n=70 Participants
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)
|
14.2 Months
Interval 10.6 to
The upper limit of the 95% confidence interval was not reached because of insufficient events.
|
9.2 Months
Interval 8.2 to 11.2
|
SECONDARY outcome
Timeframe: Baseline through the data cut-off date of 31 Aug 2011 (up to 2 years, 11 months)Population: Intent-to-treat population: All randomized patients.
Overall survival was defined as the time from randomization to the date of death from any cause. Patients who were alive at the time of analysis were censored at the date on which they were last known to be alive. Patients with no post-baseline were censored at the date of randomization plus 1 day.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=67 Participants
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
n=70 Participants
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Overall Survival
|
NA Months
The median and the upper and lower confidence intervals were not reached because of insufficient events.
|
NA Months
Interval 25.6 to
The median and the upper confidence intervals were not reached because of insufficient events.
|
SECONDARY outcome
Timeframe: Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)Population: All randomized patients with measureable disease at Baseline.
A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=67 Participants
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
n=69 Participants
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
|
64.2 Percentage of patients
Interval 51.8 to 74.8
|
58.0 Percentage of patients
Interval 45.5 to 69.2
|
SECONDARY outcome
Timeframe: Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)Population: All randomized patients with measureable disease at Baseline. Only patients with an objective response were included in the analysis.
Duration of objective response was defined as the time from initial response to investigator-assessed radiographic or clinical disease progression or death on study from any cause. For target lesions, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, disease progression was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=43 Participants
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
n=40 Participants
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
|
NA Months
Interval 15.0 to
The median and the upper confidence intervals were not reached because of insufficient events.
|
9.5 Months
Interval 6.6 to 10.6
|
SECONDARY outcome
Timeframe: Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)Population: All randomized patients with measurable disease at Baseline.
CB was defined as an objective response (complete response \[CR\], partial response \[PR\]) or stable disease (SD) for 6 months after randomization. For target lesions (TL), CR=the disappearance of all TL; PR=at least a 30% decrease in the sum of the longest diameter (LD) of TL, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of TL, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of 1 or more new lesions. For non-TL, CR=the disappearance of all non-TL; PR=the persistence of 1 or more non-TL; SD=the persistence of 1 or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits; PD=the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TL.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=67 Participants
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
n=69 Participants
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Clinical Benefit (CB) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
|
74.6 Percentage of patients
Interval 63.2 to 84.2
|
81.2 Percentage of patients
Interval 70.7 to 89.1
|
SECONDARY outcome
Timeframe: Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)Population: All randomized patients with a Baseline and at least 1 post-Baseline valid score.
Time to symptom progression was defined as the time from randomization to the first documentation of a ≥ 5-point decrease from baseline in the Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) subscale score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B questionnaire is a valid and reliable measure of symptoms associated with breast cancer. The TOI-PFB is a 24-item subscale generated using 3 subsections (Physical Well-Being \[7 items\], Functional Well-Being \[7 items\], and Additional Concerns \[10 items\]) from the FACT-B questionnaire. Patients responded to each item on a scale of 0-4 (Not at all-Very much). The total score ranged from 0 to 96. A higher score indicates fewer symptoms. A positive change score indicates improvement.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=65 Participants
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
n=67 Participants
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Time to Symptom Progression
|
7.5 Months
Interval 4.2 to 15.1
|
3.5 Months
Interval 2.1 to 6.5
|
SECONDARY outcome
Timeframe: Baseline through Cycle 5 (up to 4 months)Population: Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.
Serum samples were collected from all 67 patients enrolled in the trastuzumab emtansine arm using sparse pharmacokinetic sampling. Blood samples were collected prior to dosing and 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. Serum samples were assayed for trastuzumab emtansine and total trastuzumab (sum of unconjugated trastuzumab and emtansine conjugated to trastuzumab) in indirect sandwich ELISAs. The area under the concentration-time curve (AUC) was estimated based on non-compartmental analysis using WinNonlin (Version 5.2.1) software.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=67 Participants
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab
Trastuzumab emtansine Cycle 1 (n=62)
|
495 day•μg/mL
Standard Deviation 158
|
—
|
|
Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab
Trastuzumab emtansine Cycle 5 (n=39)
|
473 day•μg/mL
Standard Deviation 141
|
—
|
|
Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab
Total trastuzumab Cycle 1 (n=60)
|
700 day•μg/mL
Standard Deviation 260
|
—
|
|
Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab
Total trastuzumab Cycle 5 (n=38)
|
788 day•μg/mL
Standard Deviation 323
|
—
|
SECONDARY outcome
Timeframe: Baseline through Cycle 5 (up to 4 months)Population: Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.
Plasma samples were collected from all 67 patients in the trastuzumab emtansine group 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. The plasma samples were assayed for free emtansine in a mass-spectrometric assay.
Outcome measures
| Measure |
Trastuzumab Emtansine
n=67 Participants
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Plasma Concentration of Free Emtansine
Cycle 1 (n=62)
|
5.11 ng/mL
Standard Deviation 2.34
|
—
|
|
Plasma Concentration of Free Emtansine
Cycle 5 (n=39)
|
4.71 ng/mL
Standard Deviation 2.25
|
—
|
Adverse Events
Trastuzumab Emtansine
Serious events: 14 serious events
Other events: 66 other events
Deaths: 0 deaths
Trastuzumab + Docetaxel
Serious events: 17 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trastuzumab Emtansine
n=69 participants at risk
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
n=66 participants at risk
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
9.1%
6/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Chills
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Oedema peripheral
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Pyrexia
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Sudden death
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Pneumonia
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
3.0%
2/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Sepsis
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Vascular disorders
Hypertensive crisis
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Vascular disorders
Hypovolaemic shock
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
Other adverse events
| Measure |
Trastuzumab Emtansine
n=69 participants at risk
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
|
Trastuzumab + Docetaxel
n=66 participants at risk
Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
15.9%
11/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
65.2%
43/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.0%
9/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
27.3%
18/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.1%
7/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
25.8%
17/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
27.5%
19/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Cardiac disorders
Palpitations
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
3.0%
2/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Eye disorders
Lacrimation increased
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
19.7%
13/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Eye disorders
Conjunctivitis
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
4.5%
3/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Eye disorders
Dry eye
|
8.7%
6/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Nausea
|
49.3%
34/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
43.9%
29/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.9%
11/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
45.5%
30/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Vomiting
|
24.6%
17/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
25.8%
17/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Constipation
|
23.2%
16/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
22.7%
15/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Stomatitis
|
11.6%
8/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
19.7%
13/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.9%
11/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
12.1%
8/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
17.4%
12/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Dry mouth
|
15.9%
11/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
4.5%
3/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
6/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Toothache
|
2.9%
2/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
10.6%
7/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Fatigue
|
49.3%
34/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
45.5%
30/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Pyrexia
|
40.6%
28/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
22.7%
15/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Oedema peripheral
|
10.1%
7/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
42.4%
28/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Asthenia
|
23.2%
16/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
21.2%
14/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Mucosal inflammation
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
18.2%
12/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Chills
|
14.5%
10/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
7.6%
5/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Chest pain
|
8.7%
6/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Pain
|
2.9%
2/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
7.6%
5/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
General disorders
Influenza like illness
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Nasopharyngitis
|
15.9%
11/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
15.2%
10/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.5%
10/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
12.1%
8/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Urinary tract infection
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
16.7%
11/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Sinusitis
|
10.1%
7/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
7.6%
5/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Influenza
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
3.0%
2/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Pharyngitis
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
4.5%
3/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
7.6%
5/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Infections and infestations
Rhinitis
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.6%
8/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Investigations
Aspartate aminotransferase increased
|
43.5%
30/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Investigations
Alanine aminotransferase increased
|
26.1%
18/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.5%
10/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
3.0%
2/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.7%
6/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
1.5%
1/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Investigations
Platelet count decreased
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Investigations
Weight increased
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
13/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
16.7%
11/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.4%
12/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
9.1%
6/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.5%
19/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
31.8%
21/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.2%
16/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
30.3%
20/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.0%
9/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
22.7%
15/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
22.7%
15/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.1%
7/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
18.2%
12/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.0%
9/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
9.1%
6/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
4.5%
3/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
3.0%
2/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Nervous system disorders
Headache
|
40.6%
28/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
18.2%
12/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Nervous system disorders
Dysgeusia
|
8.7%
6/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
22.7%
15/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Nervous system disorders
Neuropathy peripheral
|
14.5%
10/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
15.2%
10/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
21.2%
14/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Nervous system disorders
Paraesthesia
|
8.7%
6/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
16.7%
11/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Nervous system disorders
Dizziness
|
4.3%
3/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
9.1%
6/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Nervous system disorders
Hypoaesthesia
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
4.5%
3/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Psychiatric disorders
Insomnia
|
11.6%
8/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
18.2%
12/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Psychiatric disorders
Anxiety
|
8.7%
6/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
7.6%
5/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Psychiatric disorders
Depression
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Renal and urinary disorders
Dysuria
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Reproductive system and breast disorders
Breast pain
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
12.1%
8/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.1%
18/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
21.2%
14/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.5%
10/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
27.3%
18/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
27.5%
19/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
7.6%
5/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.6%
8/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
12.1%
8/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.2%
5/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
9.1%
6/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
3/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
66.7%
44/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.4%
12/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
22.7%
15/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
10.1%
7/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
24.2%
16/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
2/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
12.1%
8/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
2/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
7.6%
5/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.7%
6/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
0.00%
0/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.8%
4/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
3.0%
2/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.9%
2/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
1/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Vascular disorders
Hypertension
|
13.0%
9/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
9.1%
6/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Vascular disorders
Hot flush
|
0.00%
0/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
15.2%
10/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Vascular disorders
Lymphoedema
|
4.3%
3/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
7.6%
5/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
|
Vascular disorders
Flushing
|
2.9%
2/69 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
6.1%
4/66 • Adverse events were collected from randomization until 30 days following the last treatment, until the early termination visit, or until treatment-related adverse events resolved or stabilized, whichever occurred first.
Safety population: All randomized patients who received at least 1 dose of study treatment. In the trastuzumab + docetaxel (T+D) group, 2 patients received no treatment and 2 patients received a dose of trastuzumab emtansine (TE) and were included in that group for safety analyses, resulting in 66 patients in the T+D group and 69 in the TE group.
|
Additional Information
Medical Communications
Genentech, Inc.
Phone: 800 821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER